MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Model Number	020250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Damage (2104); No Code Available (3191)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an open sigmoid resection procedure.This was an emergency procedure being performed to repair a tear in the sigmoid colon that occurred while the patient was undergoing a colonoscopy.It was reported that the stapler sizer also tore the tissue and had to be repaired using suture.Then the stapler was inserted trans-anally into the distal bowel and fired to anastomose the proximal and distal bowel.Upon inspection, the anastomosis was reported to have not been fully developed.The surgeon then used a smaller stapler to successfully perform the anastomosis.Finally, a diverting ileostomy was performed.Unknown at this time if the ileostomy was temporary or permanent.The surgical time was extended by more than thirty minutes due to the product problem.The was patient injury.

• Brand Name: EEA
• Common Device Name: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8747959
• Report Number: 1219930-2019-03853
• Device Sequence Number: 2398170
• Product Code: KOA
• UDI-Device Identifier: 10884521047471
• UDI-Public: 10884521047471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 020250
• Device Catalogue Number: 020250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention