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

Model Number EL5ML

Device Problems Failure to Form Staple (2579); Insufficient Information (3190)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic cholecystectomy, the firing sound became unusual and clip scissoring occurred suddenly during use.The device was used on the blood vessels.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.There was no bleeding, leakage, or damage to the tissue due to the clip malforming.The patient is stable.

Manufacturer Narrative

(b)(4).Date sent: 9/2/2022 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 no damage to the external components.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips, as a result, the instrument could no longer be fire due to the activation of the lockout mechanism.The event described could not be confirmed as the device was returned empty.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: when the 13th clip is fired, an orange bar will begin to appear in the indicator window on top of the device handle.The orange bar fills the indicator window when the final clip is fired.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• 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 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15218719
• MDR Text Key: 305350810
• Report Number: 3005075853-2022-05255
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: X94N8T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1