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

Model Number EL5ML

Device Problem Failure to Fire (2610)

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

Event Date 01/21/2020

Event Type  malfunction  

Event Description

5mm endoscopic clip applier would not fire.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 9811049
• MDR Text Key: 182735186
• Report Number: 9811049
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: (01)10705036001843
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• 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: P00019P67
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA