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

Model Number EL5ML

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, when the surgeon was going to fire the device, the clips weren't closed completely.As an emergency measure, the surgeon replaced it with a new one to complete the procedure and it was closed very well.There were no reported adverse consequences for the patient.

Manufacturer Narrative

(b)(4).D4: batch # r93d12.Investigation summary : the analysis results for the el5ml device found that it was returned with the shaft bent.No functional testing could be performed due to the returned condition of the device.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.11 clips were found inside clip track.Possible causes for the damage found may be inadvertent pressure placed on the device shaft through bending, pressing against the trocar, other devices on the back table, using the device as a retractor, or moving heavy tissue with the device shaft.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9505723
• MDR Text Key: 188358571
• Report Number: 3005075853-2019-24665
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

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 Expiration Date: 04/24/2023
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: R40K4R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/17/2020
• Patient Sequence Number: 1