MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED SHORT APPLIER; CLIP, IMPLANTABLE

Catalog Number	MSM20
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 6/10/2025 d4 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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: did device jammed (not fire clips)? did device not feed clips? did device drop or eject clips? did device sideways feed clips? did device fire malformed clips? did device fire scissored clips? if other please specify 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 or Problem Description
It was reported that during an unknown procedure there were loose clips when applying.Some falling out¿.Very generic feedback and no specific details.No surgical issues as a result.There was no surgical delay.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/27/2025.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 7/2/2025.D4 batch #y7028z.Investigation summary- the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the msm20 device was returned with the shaft bent.In addition, the tyvek was returned along with the instrument.Due to this condition, no functional testing could be performed to evaluate the reported incident.Three(3) clips were found inside clip track.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Possible causes for the damage found may be inadvertent pressure placed on the device shaft through bending, pressing against other devices on the back table, using the device as a retractor or moving heavy tissue with the device shaft.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch y7028z number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4) date sent: 7/7/2025 additional information was requested, and the following was obtained: how did device not work? did device jammed (not fire clips)? did device not feed clips? did device drop or eject clips? did device sideways feed clips? did device fire malformed clips? did device fire scissored clips? if other please specify when information requested, the staff had nothing else to add.

• Common Device Name: 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 ; 3035526892
• MDR Report Key: 22177856
• Report Number: 3005075853-2025-04387
• Device Sequence Number: 12710063
• Product Code: GDO
• UDI-Device Identifier: 10705036002505
• UDI-Public: (01)10705036002505(17)290630(10)182D96
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K820837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/07/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: MSM20
• Device Lot Number: 182D96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 07/01/2025; 07/02/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/27/2025; 07/02/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown