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

Model Number	030412
Medical Device Problem Codes	Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading unit was fully fired, the interlock was engaged, the clamping mechanism was deformed, the loading unit anvil was bowed, staple pushers were partially flush with the cartridge, and one of the adapter lugs was damaged.Functional testing required the interlock to be overridden and the loading unit was applied to test media.The interlock was tested and found to function properly.It was reported that the device was difficult to unload.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur either by application over tissue that is beyond the recommended thickness range, or application with an obstacle incorporated in the jaws.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: select a loading unit with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.Always include the combined thickness of the tissue and of any staple line reinforcement material in use when choosing the proper staple cartridge.When positioning the instrument on the application site, ensure that no obstructions, such as previously fired staples or clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic roux en y gastric bypass, the handle was able to recognize the reload and stapler was able to fire, but the reload would not unload.A manual handle was then used to complete the case.There was no patient injury.Medtronic's initial evaluation of the incident device found that a loading unit with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.Always include the combined thickness of the tissue and of any staple line reinforcement material in use when choosing the proper staple cartridge.When positioning the instrument on the application site, ensure that no obstructions, such as previously fired staples or clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.

• 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: 10883327
• Report Number: 1219930-2020-04930
• Device Sequence Number: 3228513
• Product Code: GDW
• UDI-Device Identifier: 10884523002911
• UDI-Public: 10884523002911
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/23/2020

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 Model Number: 030412
• Device Catalogue Number: 030412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 134