Reference no: EM134013868

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 week 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

Question:

With reference to the reviewed clinical sequence above, answer the following questions on risk identification and risk analysis.

1. Risk Identification: Using the clinical sequence above, identify potential risks involved. Explain how each identified risk a risk to the assets of the hospital (i.e. how can this risk affect the profitability of the company).

2. Risk Analysis: For each of the identified risks, estimate (subjectively): a. the possibility that this risk will occur in the future (frequency) as either low frequency, medium frequency, or high frequency and justify these choices, and ; b. the average size of the risk (severity) as either low severity, medium severity, or high severity and justify the choice of severity.