MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN SIGNIA EGIA ADAPTER; STAPLE, IMPLANTABLE

Model Number UNKNOWN SIGNIA EGIA ADAPTER

Device Problem Entrapment of Device (1212)

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

Event Date 02/17/2024

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic pancreatectomy, after stapling the pancreas, the jaws did not open and locked on tissue.The surgeon used a retraction key to open the reload.There was no patient injury.

Manufacturer Narrative

D10 concomitant product: egia60avm - egia60avm egia 60 artic vasc med sulu.Lot# p2c1065 sigphandle - sig power sigphandle handle, serial# unknown.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: UNKNOWN SIGNIA EGIA ADAPTER
• 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: 19008410
• MDR Text Key: 339041674
• Report Number: 1219930-2024-01385
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SIGNIA EGIA ADAPTER
• Device Catalogue Number: UNKNOWN SIGNIA EGIA ADAPTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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
• Patient Sex: Female