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

Model Number EGIA60AMT

Device Problems Misfire (2532); Failure to Form Staple (2579); Detachment of Device or Device Component (2907)

Patient Problem Tissue Breakdown (2681)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

According to the reporter, in a laparoscopic bariatric sleeve gastroplasty, during gastric stapling, the device fired but the doctor was unable to perform full stapling.The reload partially fired.Only the beginning part were stapled, some of the staples stayed open in the cavity while the rest stayed in the reload and did not cut the tissue.Some of the fired staples were also malformed.Four more reloads from another lot was used but the same issue occurred.The stapler was switched to a powered stapler and the stapling was completed.The malformed staples were removed and new stapling was carried out with another reload.The staples that fell into the cavity were removed by using forceps and sterile gauze.The surgical time was extended for 30 minutes or more due to the replacement of the faulty devices.

Manufacturer Narrative

D10 concomitant product: egia45amt egia 45 artic med thick sulu (lot#: p2m0197); egia60amt egia 60 artic med thick sulu (lot#: p2l0397); egia60amt egia 60 artic med thick sulu (lot#: p2l0397); egia60amt egia 60 artic med thick sulu (lot#: p2l0397); egiauxl endogia ultra univ xl stapler (lot#: p2l0508) 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.

Manufacturer Narrative

Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.Visual inspection noted malformed staples being retrieved from a patient during a surgical procedure.The first video showed grasping tools being used to show the staple line which has malformed staples.The second video showed the reload clamped on an organ and the grasping tool moving around during a surgical procedure.It was reported that the reload partially fired.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that a component disengaged and some staples were also malformed.The reported issues were confirmed.The most likely cause could not be established from the information available.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.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
• 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: 18993245
• MDR Text Key: 338914426
• Report Number: 2647580-2024-01410
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003215
• UDI-Public: 10884523003215
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: P2L0397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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 NOTE ON H11.
• Patient Age: 42 YR
• Patient Sex: Male