MAUDE Adverse Event Report: COVIDIEN COVIDIEN TRI-STAPLE; STAPLE, IMPLANTABLE

Model Number GIA80MTS

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

Pt (patient) had to return to surgery for repair of complications.Question possibility that staples used in the staple gun were a contributing cause of the complications.

• Brand Name: COVIDIEN TRI-STAPLE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 17327435
• MDR Text Key: 319119301
• Report Number: MW5119436
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIA80MTS
• Device Lot Number: N2K0675UY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: STAPLE GUN.
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 74 KG