MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030412
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on a laparoscopic nephrectomy, the device did not fire.The surgeon was able to press the green button but was unable to squeeze the handle.The device could not close on to the uterine vessel.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the jaws of the reload did not close completely.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on a laparoscopic nephrectomy, the device did not fire.The jaws of the device could not fully close onto the uterine vessel, so the device did not fire.The surgeon was able to press the green button but was unable to squeeze the handle.Another reload was used with the same handle to complete the case.There was no patient injury.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12562043
• Report Number: 2647580-2021-03331
• Device Sequence Number: 1416198
• Product Code: GDW
• UDI-Device Identifier: 10884523002911
• UDI-Public: 10884523002911
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 11/30/2024
• Device Model Number: 030412
• Device Catalogue Number: 030412
• Device Lot Number: P9M1533MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown