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

Model Number LIGAMAX5

Device Problems Defective Component (2292); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

Clipper being used during a gallbladder procedure misfired several times causing the clips to crisscross or feather.A new clipper was acquired and defective one taken out of service.No harm was done to patient.Fda safety report id # (b)(4).

• Brand Name: LIGAMAX5 ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.
• MDR Report Key: 9910013
• MDR Text Key: 186137013
• Report Number: MW5093986
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIGAMAX5
• Device Catalogue Number: EL5ML
• Device Lot Number: U93603
• Was Device Available for Evaluation?: No
• 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: 57 YR
• Patient Weight: 54