Device Vendors Distract Surgical Team

Description

Following surgery for rectal prolapse—which involved a malfunctioning stapling device—a 53-year-old male experienced complications and required additional surgery.

Key Lessons

• Policies for trial device assessment must ensure they prevent use of an unapproved trial device.
• Comprehensive pre-operative planning protects patients and providers.

Clinical Sequence

A 53-year-old man with long-standing history of rectal prolapse presented for elective sigmoid resection with rectopexy.

The patient underwent a pre-operative surgical office consultation weeks prior to surgery and was apprised of the surgical risks, including bleeding, infection, injury to organs, anastomotic leak, need for temporary (or permanent) ostomy, pain or injury to nerves affecting urinary or sexual function. There was no documented discussion of potential use of an experimental device or the associated risks of such mechanical devices to be utilized during the surgery.

A day before the surgery, the patient was admitted for bowel prep. The morning of the surgery, the surgeon again reviewed how the procedure would be performed and described the associated risks. Meanwhile, two representatives of a stapling device vendor requested access to the OR to oversee the trial of a new stapler. The hospital’s policy for vendor access to the OR required approval by the Materials Department for use of trial devices, after which the representatives could be provided ID badges for access to the OR suite. In this case, the attending surgeon informed the vendors that they must obtain an ID badge to gain access to the OR without clearly articulating the steps for approval of trial devices.

When the vendors returned to the OR with ID badges, the surgeon granted them access to the OR.

As the surgeon applied the trial stapler in performing the anastomosis, it closed around the distal sigmoid colon and rectum, but would not re-open. After 45 minutes of trouble-shooting with the vendor representatives—including replacing batteries—the surgical team elected to re-open the sigmoid colon and resect the rectum to remove the stapler. During this process, part of the rectum was torn and multiple staples were lost in the operative space. These complications required that the patient undergo a diverted loop colostomy, requiring surgical reversal.

The surgeon disclosed this event to the patient, who underwent an uncomplicated recovery and surgical reversal seven months later.

Allegation

The patient filed a claim against the hospital claiming that improper performance of surgery, i.e., utilizing an unapproved device, caused preventable complications and required additional surgery.

Disposition

After unsuccessful mediation between both parties, the case was settled in the low range.

Analysis

The policy for vendor representatives gaining approved access to the OR, and use of a trial device, was easily bypassed.

Although the surgeon might have set clearer expectations regarding safety approval and OR access for the vendor, this responsibility is more appropriately held by the OR staff and Materials Department. A fail-safe check and balance system, even as simple as requiring signed approvals from Materials and the OR administrator, would decrease the opportunity for ambiguity. Transferring approval responsibility away from the surgeon also decreases the potential conflict of interest that may arise when a clinician is responsible for monitoring vendor access to the OR.

The OR staff was not informed prior to the procedure that a trial device would be used.

The entire care team should be properly informed when trial devices or techniques will be used. A pre-surgery huddle provides an opportunity to review the procedure plan, including use of new devices or techniques and potential complications. This allows the team to a) ensure that the policy for outside vendors is followed, b) ask questions regarding potential malfunction or technical complications, and c) formulate appropriate recovery and management strategies to mitigate these risks.

The pre-surgery consent process did not cover the trial use of the stapler.

Had the patient been advised of possible risks associated with a trial device, he may have been better prepared for the outcome in this case.