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 11/22/2021

Event Type  malfunction  

Event Description

It was reported that during a hysterectomy procedure,the el5ml was damaged after the first "pin" came out.One side of jaw was completely damaged.It is unknown how the procedure was completed.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Batch # unk.Attempts are being made to obtain additional information and 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: were there any patient consequences? if yes, please describe.How were jaws damaged (please specifically describe the damage)? did any piece of jaw fall off of device? is so, was piece retrieved? will piece be returned for analysis? a manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 4/15/2022.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 received with one jaw broken at bifurcation.The device was disassembled and evidence of corrosion was found throughout the broken area.10 remaining clips were found on the clip track.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 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.

• 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: 13031835
• MDR Text Key: 282615421
• Report Number: 3005075853-2021-07927
• 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
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1