MAUDE Adverse Event Report: COVIDIEN LLC PROTACK; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number 174006

Device Problems Device Inoperable (1663); Failure to Fire (2610); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Event Description

During a laparoscopic inguinal surgery, as the mesh was being implanted, a device used to suture the mesh into the patient did not fire correctly and instead jammed and was no longer functional.

• Brand Name: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7619715
• MDR Text Key: 111699824
• Report Number: 7619715
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2021
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P6H0721PX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 72 YR
• Patient Weight: 71