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

Model Number 174006

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/22/2017

Event Type  malfunction  

Event Description

Supply used to tack mesh broke at shaft.Protack fixation device 5mm by covidien ref (b)(4) lot # p7d1286px.

• Brand Name: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 6897291
• MDR Text Key: 87514432
• Report Number: 6897291
• 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: Other
• Type of Report: Initial
• Report Date: 08/25/2017,09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2022
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P7D1286PX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 48 YR
• Patient Weight: 108