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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); No Apparent Adverse Event (3189); Firing Problem (4011)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.Date of event is 2021.Event day and event month were not reported.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, no additional information has been received and no device has 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 the surgeon was performing a lap chole procedure.He dissected out the cystic duct and cystic artery, asked for the clip applier, and applied them in usual fashion.Very shortly after, he encountered bleeding.Upon exploration, it was noticed that the clips he has placed had fallen off.He tried reapplying.These clips also did not stay in place.Surgeon stated that he felt that handpiece was more difficult than usual to squeeze.Opened a new clip applier, applied clips, and no problems were observed with the new applier.There was no patient consequence.

Manufacturer Narrative

(b)(4).Date sent: 9/2/2021.D4: batch # v94j5h investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the el5ml device was received with no damage to the external components.In addition, the jaws of the clip applier were also inspected and no burrs or sharp edges were observed.Upon cycling, the instrument was noted to be empty, however, the lockout mechanism was non-functional.Upon disassembly od the device, the ratchet pawl was found to be damaged, causing the lockout feature.The damage observed on the ratchet pawl from the complaint device is consistent with a device that has been fired through lockout.As the complaint device was returned empty with no clips remaining, it was concluded that after the device fired all clips, the firing of the device was continued, thus breaking through the lockout which damaged the ratchet pawl component.The ratchet pawl damage is related to improper use of the device.The instructions for use contain the following: "caution: the instrument contains a last clip lockout feature designed to increase the force required to close the trigger, thereby reducing the possibility that the empty jaws will be closed on a structure or vessel.Do not attempt to fire through the lockout." as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is 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: 12278572
• MDR Text Key: 265389329
• Report Number: 3005075853-2021-04476
• 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
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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: V94J5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 09/02/2021
• Patient Sequence Number: 1