MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LIGAMAX 5 MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problem Misfire (2532)

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

Event Date 12/31/2019

Event Type  malfunction  

Event Description

Md stated that clip applier felt like it was getting stuck and then misfired twice.Fda safety report id# (b)(4).

• Brand Name: LIGAMAX 5 MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC ; guaynabo PR 00969
• MDR Report Key: 9569587
• MDR Text Key: 174671187
• Report Number: MW5092124
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Device Lot Number: T94V89
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• 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: 43 YR
• Patient Weight: 57