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

Catalog Number	MCL20
Medical Device Problem Codes	Failure to Form Staple (2579); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/1/2025.D4: batch # unk.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: "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 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 or Problem Description
It was reported that during an unknown procedure, clips slid off vessel.Hemorrhage, stress, and increased operative time and anesthesia duration.Another device was used.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/5/2025 additional information was requested, and the following was obtained: how did device not work? - the device worked.Did device jammed (not fire clips)? - the clips were triggered.Did device not feed clips? - the clips were delivered.Did device drop or eject clips? - the device did not drop or eject the clips.Did device sideways feed clips? - i don¿t know.This may be an explanation for the poor retention of the clips on the vessels.Did device fire malformed clips? - i don¿t know.This may be another explanation for the poor retention of the clips on the vessels.Did device fire scissored clips? - i don¿t know for this device, but another material vigilance report was made when clips cut vessels.If other please specify is the current patient status known? - i don¿t know.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.) - i don¿t know.
Additional Manufacturer Narrative
(b)(4) date sent 5/27/2025 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 6/3/2025.D4 batch #x95r2w.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 mcl20 device was returned with a clip in jaws and with no apparent damage.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining sixteen(16) clips as intended.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: ensure that a clip is in the jaws.Position the jaws so that the clip completely surrounds the vessel to be ligated.Fully squeeze the handles together until they stop.As the handles are squeezed, the clip closes and occludes the vessel or tubular structure.Fully release the handles to return the instrument to its original open position.The next clip is automatically advanced.Inspect the jaws after each clip application to ensure the presence of a new clip before applying the next clip.Repeat steps as necessary to continue ligation of tissue.For optimal performance, periodically clean the instrument during the procedure by submerging the jaw and distal end of the applier shaft in saline.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch x95r2w number, and no non-conformances were identified.

• 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: 21945121
• Report Number: 3005075853-2025-03259
• Device Sequence Number: 13042052
• Product Code: GDO
• UDI-Device Identifier: 10705036002468
• UDI-Public: (01)10705036002468(17)270831(10)979A60
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2025

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: MCL20
• Device Lot Number: 979A60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 05/22/2025; 06/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/05/2025; 05/27/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown