MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIAADAPTXL
Medical Device Problem Codes	Entrapment of Device (1212); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a robotic laparoscopic lower anterior resection on the rectum, the device, was unable to unload but was able to fire the jaws of the device also locked on tissue, the device was unable to retract post firing.There was an unanticipated tissue loss as a result of the problem.The surgical time was extended by 30 minutes or more.The incision was extended by more than 1 inch or 2.54cm.Because of the misfiring of stapler, the doctor had to do a colostomy.The rectum was resected using a manual stapler and the instrument was removed to complete the case.The patient was still in the hospital.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7969196
• Report Number: 1219930-2018-05505
• Device Sequence Number: 1738995
• Product Code: GDW
• UDI-Device Identifier: 10884521201989
• UDI-Public: 10884521201989
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K133762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: C2017C392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 02/27/2019
• 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: Hospitalization; Required Intervention