MAUDE Adverse Event Report: ETHICON, INC. 5MM LAPROSCOPIC CLIP APPLIER; CLIP, IMPLANTABLE

Lot Number U93J1F

Device Problem Misfire (2532)

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

Event Type  Injury  

Event Description

During a laparoscopic cholecystectomy, the clip applier misfired four times, and was removed from service.The clip applier was tested prior to use, and worked w/o difficulty on the first clip.A replacement was obtained, and the surgeon corrected the misfired clips with replacement ones, and all of the prior clips were removed.No concern for any retained foreign objects.Fda safety report id # (b)(4).

• Brand Name: 5MM LAPROSCOPIC CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 10483223
• MDR Text Key: 205522503
• Report Number: MW5096389
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: U93J1F
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR