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

Model Number MCM20

Device Problems Failure to Fire (2610); Mechanics Altered (2984); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 was the bleeding controlled? how much bleeding occurred? were any blood products given? if yes, how much? what is current patient status?" a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 an unknown procedure, the ligaclip multiclip appliers were not producing clips when handles clicked, resulted in a vessel being cut and no clip was applied.

Manufacturer Narrative

(b)(4).Date sent: 12/08/2022.D4: batch # v96d3f.Additional information was requested and the following was obtained: "what is the current patient status/ outcome? essentially normal outcome as we were able to control the bleeding how much was the blood loss? estimated blood loss 200ml was there a change in blood pressure? no change in blood pressure was there transfusion required? no transfusion required.How was the bleeding controlled? fortunately the chest has undergone previous radiotherapy and so the vessel was very stiff and didn¿t retract.The blood was evacuated and pressure enabled a further clip to be placed on the vessel.If the vessel retracted we would have had significant profuse bleeding that would have required further rib resection to control." 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 revealed that the mcm20 device was returned with no apparent damage.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 3 clips as intended.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.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15770393
• MDR Text Key: 307282812
• Report Number: 3005075853-2022-07745
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K820837
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCM20
• Device Catalogue Number: MCM20
• Device Lot Number: 582A23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1