MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOSCOPIC MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  Injury  

Event Description

During a laparoscopic cholecystectomy, a 5mm laparoscopic clip applier misfired and was removed from the field.A new clip applier was used and the procedure was completed without incident.Discussed w/surgeon, there were no unintended clips left in patient, and there was no patient harm.Fda safety report id # (b)(4).

• Brand Name: ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 10811323
• MDR Text Key: 215539332
• Report Number: MW5097721
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 22 YR