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

Catalog Number EL5ML

Device Problem Mechanical Problem (1384)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/16/2024.D4: batch # x7048h.Investigation summary.The product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device 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 damages was found on the jaws.Fourteen(14) 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 and lot number, and no non-conformances were identified.

Event Description

It was reported that prior to an unknown procedure, when the device was opened it was found to be bent.Another like device was used to continue with the procedure.There were no adverse consequences for the patient.

• 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 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19121747
• MDR Text Key: 340341972
• Report Number: 3005075853-2024-02969
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

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 Catalogue Number: EL5ML
• Device Lot Number: X7048H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1