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

Catalog Number EL5ML

Device Problem Failure to Form Staple (2579)

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

Event Date 04/15/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/25/2024.D4: batch # x70536.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "-were the jaws of the device yielded, damaged, bent, misaligned or broken? -did device fire scissored clips? this may also include ribbon shaped or x-shaped.-did device fire malformed clips?pear/tear drop shape or clip gap? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.)" 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.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 bladder procedure, the clips did not close properly, the jaws crossed.

Manufacturer Narrative

(b)(4).Date sent: 5/21/2024.Correction: h6.Medical device problem code.H6.Health effect - impact code.Additional information was requested and the following was obtained: "answers to pcf (provided by the customer by email): were the jaws of the device yielded, damaged, bent, misaligned or broken? the jaws were not damaged, but they crossed when closing.Did device fire scissored clips? no.Did device fire malformed clips?pear/tear drop shape or clip gap? no.Is the current patient status known? yes.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? no, but surgical delay and use of another device to complete the procedure.".

• 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: 19184035
• MDR Text Key: 341468945
• Report Number: 3005075853-2024-03227
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• 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: X70536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1