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

Model Number	EGIARADMT
Medical Device Problem Codes	Misfire (2532); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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 one of the returned devices to be partially fired.Functional testing found both reloads were connected to a manual handle, were able to clamp, had their interlocks engaged, and were able to fire over test media after the interlocks were overridden.The remaining staples were placed without issues.The tissue was cut without issues.It was reported that the device detected a used reload.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when stapling the intestinal loop during a laparoscopic retosynthictomy, the surgeon repositioned the tissue and the device¿s trigger signaled that the device was ready for firing.However, the first load that was used did not neither staple not cut.The device signaled zeroed load then.A second load of the same batch was opened which stapled halfway and left the stapler line open and device signaled zero load again without fully stapling.The surgeon then used another stapler and two reloads that also did not complete the stapling on the tissue.The stapler locked and did not work.To finish the procedure the surgeon reverted to open via anal.

• 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: 12129975
• Report Number: 1219930-2021-02689
• Device Sequence Number: 4700469
• Product Code: GDW
• UDI-Device Identifier: 10884521057784
• UDI-Public: 10884521057784
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/07/2021

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: EGIARADMT
• Device Catalogue Number: EGIARADMT
• Device Lot Number: N7G0769X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/07/2021
• 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
• Patient Age: 52 YR