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

Model Number	EGIATRS45AMT
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The reload was herniated and received attached to the powered adapter.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.The root cause of the observed condition was determined to be a result of a manufacturing activity.A stray wire clipping caused a short on the motor board in the handle causing the motor to move in an unintended direction.Improvements have been initiated to mitigate this condition.Based on the evidence available the reported condition was confirmed however the failure is being attributed to the powered handle.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during a gastric sleeve procedure, the handle was prepared for use.When an attempt was made to open the jaws as part of the preparation and before use on the patient, there was an abnormal surging sound.The knife advanced and protruded though the articulation joint, and the reload articulated 45 degrees.When attempting to straighten, open, and remove the reload, the reload became partially disconnected from the adapter.The reload could not be fully removed from the adapter.The reload and adapter were then removed together from the handle.A second adapter was placed on the handle, but a reload could not be connected.The firing rod in the adapter appeared to be protruding.The patient was not involved at the time this incident occurred.The procedure was completed with a new shell and a new reload.

• 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: 8376066
• Report Number: 1219930-2019-01176
• Device Sequence Number: 2287933
• Product Code: GDW
• UDI-Device Identifier: 10884521190887
• UDI-Public: 10884521190887
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K133938
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Device Lot Number: N6K0734KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial 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