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

Model Number 5MM

Device Problem Firing Problem (4011)

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

Event Date 12/27/2022

Event Type  malfunction  

Event Description

Ethicon endoscopic multiple clip applier 5mm (ref el5ml) while using during surgery clip applier failed to fire correctly while inside the pt.

• Brand Name: ETHICON ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON/ ETHICON ENDO-SURGERY, INC.; guaynabo PR
• MDR Report Key: 16157547
• MDR Text Key: 307499764
• Report Number: MW5114319
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5MM
• Device Catalogue Number: EL5ML
• Device Lot Number: W7013T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1