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 2.54 cm.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.Due to the issue the doctor had to perform a colostomy.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation of the adapter noted that the lock out slider block was damaged, and the non-welded tip housing was damaged.The articulation rod was bent.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Damage to the lockout slider block is consistent with a user attempting to fire a single use loading unit (sulu) when one is not fully attached.If the reload is not fully attached this can also cause the firing rod to be poorly engaged with the reload.When the block becomes jammed it can prevent the lockout cam block and sulu load link from returning to its resting state.The sulu load link connects to the "unload" button, in turn causing that to become stuck in place.Damage to unload button can be replicated through rough handling.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 8371928
• Report Number: 1219930-2019-01130
• Device Sequence Number: 2024571
• 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): 04/11/2019

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: C2017C397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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