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

Model Number EL5ML

Device Problem Insufficient Information (3190)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u95w38.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 one jaw disengaged from the cam.This condition would not allow the jaws to collapse in order to form the clips.In addition, one malformed clip was returned inside a plastic bag.No functional testing was performed due the condition of the device.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembly, no anomalies were found.In addition, three clips were found inside the clip track.No conclusion could be reached regarding what caused the jaw disengagement.The reported event is confirmed and although no conclusion could be reached regarding the cause of the reported event, the instructions for use contain the following: "caution: possible causes for the condition of the jaw disengagement from the cam may be due to inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor, or damage to the jaws while entering the trocar." 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-conformance were identified.

Event Description

It was reported that during a laparoscopic sigmoidectomy, it was found the device was broken off during use.Before the procedure, a laparoscopic cholecystectomy, was performed.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 12022208
• MDR Text Key: 260956209
• Report Number: 3005075853-2021-03409
• 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: 06/16/2021

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: U95W38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1