MAUDE Adverse Event Report: COVIDIEN PROTACK AUTO SUTURE FIXATION DEVICE 5MM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 174006

Device Problem Failure to Fire (2610)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Protack autosuture fixation device was opened and in the cavity when it was discovered to not fire.A second protack was opened for the case.

• Brand Name: PROTACK AUTO SUTURE FIXATION DEVICE 5MM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16690470
• MDR Text Key: 312877092
• Report Number: MW5116392
• Device Sequence Number: 1
• Product Code: OCW
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174006
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White