MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. LIGAMAX; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problem Misfire (2532)

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

Event Date 01/09/2020

Event Type  malfunction  

Event Description

Ethicon ligamax 5 endoscopic multiple clip applier 5 mm (el5ml) used during laparoscopic cholecystectomy.Clip applier misfired/malfunctioned.Second clip applier (same model) used also misfired/malfunctioned.No harm to the patient.Both clips from same lot.Both retained and the remainder of same lot no.Have been removed from stock.Manufacturer response for endoscopic multiple clip applier - 5mm, (brand not provided) (per site reporter).They have been sent back for evaluation.The clip appliers were sent back.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 10017113
• MDR Text Key: 189600119
• Report Number: 10017113
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: T94048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA