MAUDE Adverse Event Report: COVIDIEN ENDO CLIP - CLIP APPLIER; CLIP, IMPLANTABLE

Model Number 176620

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

Dr.(b)(6) performed a laparoscopic cholecystectomy on a patient.While doing the cholangiogram portion, the clip applier misfired several clips (not completely clamping the tissue).Fda safety report id # (b)(4).

• Brand Name: ENDO CLIP - CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10852033
• MDR Text Key: 216895938
• Report Number: MW5097926
• Device Sequence Number: 1
• Product Code: FZP
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176620
• Device Catalogue Number: 176620
• Device Lot Number: T9M052X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 57