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

Model Number EGIA60AMT

Device Problems Break (1069); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: sigadaptshort, sig power sigadaptshort lin short adapt (serial#: (b)(6)); sigphandle, sig power sigphandle handle (serial#: unknown); sigpshell, sig power sigpshell control shell (lot#: n3j2117y).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 oesophagectomy procedure, before using on the patient, the reload would not go on the adapter properly, hence the device could not be used for firing.Visually, the black ring connection part of the reload broke, and then the reload would not come off either.To resolve the issue, another reload and adapter was used.There was no patient injury.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the reload was received attached to the returned adapter.The jaws were open.The reload had a full complement of staple.The proximal end of the reload adapter was broken.The lock ring was observed to be broken.The reload was only connected to the adapter by the articulation flag, which was found to be bent.It was reported that the reload would not go on the adapter, the black ring connection part of the reload broke and the reload would not come off.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues can occur if the loading unit is forcefully rotated while only partially inserted into the instrument shaft or if trying to remove loading unit without articulation lever being in neutral position.Also, these issues may occur due to improper orientation of the lock ring or over-flexure of the reload while attached to the instrument, over-torqueing during unloading, or if an attempt is made to unload the reload without using the release button.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: do not attempt to insert or remove the instrument from the trocar sleeve if the instrument is in the articulated position.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19110867
• MDR Text Key: 340352605
• Report Number: 1219930-2024-01598
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003215
• UDI-Public: 10884523003215
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/15/2024

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
• Device Operator: Health Professional
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: N3G1558Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2023
• 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