MAUDE Adverse Event Report: COVIDIEN COVIDIEN GIA STAPLER, 60MM; STAPLE, IMPLANTABLE

Model Number GIA60MTC

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2022

Event Type  malfunction  

Event Description

Gia stapler would not advance.Had to remove from bowel and use another stapler.

• Brand Name: COVIDIEN GIA STAPLER, 60MM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 14975953
• MDR Text Key: 295603367
• Report Number: 14975953
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2022,06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: GIA60MTC
• Device Catalogue Number: GIA60MTS
• Device Lot Number: N1K0716UY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2022
• Date Report to Manufacturer: 07/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male