MAUDE Adverse Event Report: COVIDIEN LP PREMIUM SURGICLIP II; CLIP, IMPLANTABLE

Model Number 134053

Device Problems Failure to Align (2522); Firing Problem (4011); Physical Resistance/Sticking (4012)

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

Event Date 06/17/2020

Event Type  malfunction  

Event Description

While using disposable clip applier during surgery, surgeon noted that clips were not lined up properly and handle was getting stuck when firing.Surgeon tried multiple appliers from the same box with same results.

• Brand Name: PREMIUM SURGICLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 10307346
• MDR Text Key: 199859444
• Report Number: 10307346
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057579
• UDI-Public: (01)10884521057579
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 134053
• Device Catalogue Number: 134053
• Device Lot Number: P0B1452Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA