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

Model Number EGIAUSTND

Device Problems Retraction Problem (1536); Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant products: box00662v1, box appendectomy kit 3.5mm blue (lot#0227888036) 030419, 030419 endo giaii 30 3.5mm dlu x6 (lot#p2b0057) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, during a laparoscopic appendectomy procedure, when stapling the appendix, the surgeon had a problem with firing the stapler.It was only half of the staples that were possible to fire, and it could not fire the rest, but it was enough to staple the appendix because it was thin.Also, the surgeon had problem withdrawing the knife afterwards.It was noted that the jaws were not locked on the tissue.There was no patient injury.

Manufacturer Narrative

H3 evaluation summary: 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 device is not firing 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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDO GIA ULTRA
• Type of Device: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19093979
• MDR Text Key: 340015769
• Report Number: 2647580-2024-01608
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003543
• UDI-Public: 10884523003543
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P3H0983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 83 KG