MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOSCOPIC MULTIPLE CLIP APPLIER - LIGAMAX5; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Ethicon endo-surgery endoscopic multiple clip applier/ligamax5, made a grinding sound following the 5th firing and would no longer discharge clips.Fda safety report id # (b)(4).

• Brand Name: ENDOSCOPIC MULTIPLE CLIP APPLIER - LIGAMAX5
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC
• MDR Report Key: 13506484
• MDR Text Key: 285530514
• Report Number: MW5107355
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: V9675Z
• 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
• Patient Sex: Male
• Patient Race: White