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

Model Number EL5ML

Device Problem Mechanical Problem (1384)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been 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.A manufacturing record evaluation was performed for the finished device lot numberand no non-conformances were identified.

Event Description

It was reported that during a hysterectomy procedure, the device got damaged.The tip of the device was broken after using and "pins" were jammed in it.No fragments were generated, surgery was successfully completed, and there was no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 4/15/2022.

Manufacturer Narrative

(b)(4).Date sent: 6/30/2022.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the el5ml found that the device was received with one of the jaws protruding from its normal position.Upon cycling, the instrument was noted to be locked out.The device was disassembled, and one of the jaws was noted to be broken at the bifurcation area, evidence of corrosion was found throughout the broken area.Also, no clips were found on the clip track, the device was received empty.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event reported was confirmed and it is related to improper use of the device.The most likely reason for jaw bifurcation breakage is stress corrosion cracking and the most likely root cause is exposure to a solution containing chlorine.The reported complaint was confirmed.In addition, in order to avoid this kind of issues please do not reuse, reprocess, or re-sterilize the device.Reuse, reprocessing or re sterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness or death.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 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: 13032400
• MDR Text Key: 289354657
• Report Number: 3005075853-2021-07930
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

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: V94099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 03/29/2022; 06/23/2022
• Supplement Dates FDA Received: 04/15/2022; 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1