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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, after approximately half way through successfully fired clips, the incident occurred.A malformed clip at the top of the instrument blocked further usage.It is unknown how procedure was completed.There was no patient consequence.

Manufacturer Narrative

(b)(4).Date sent: 12/9/2020; d4: batch # u94d1a.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, one jaw broken at bifurcation was found.This condition was likely caused due to damage in the shaft and two clips were found inside clip track.No conclusion could be reached on what caused the malformed clip.Possible causes for the damage on the shaft found may be due to inadvertent pressure being 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.Please reference the instruction for use for more information.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: 10815989
• MDR Text Key: 215516935
• Report Number: 3005075853-2020-05867
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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 Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: U94D1A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 12/09/2020
• Patient Sequence Number: 1