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

Model Number EL5ML

Device Problems Mechanical Problem (1384); Firing Problem (4011)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: v9477l.(b)(4).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 the el5ml device was received with no damage to the external components.Upon cycling, the instrument was noted to be empty, however, the lockout mechanism was non-functional.Upon disassembling the device, the ratchet pawl was found damaged, causing the lockout feature.Also, the advancer was noted to be bent.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 was 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." the condition of the bent advanced was related to improper use of the device."please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.Please reference the instructions for use for more information." 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 lot/batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the clip applier was not working.It would clamp down and clip would come out after released.Used bipolar or diathermy instead and surgery was successfully completed.There was no patient consequence.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12595523
• MDR Text Key: 275407331
• Report Number: 3005075853-2021-06052
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2021

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: V9477L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1