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

Model Number MCM20

Device Problems Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that during a unknown procedure there were several ligaclips that were opened and all appeared to misfire / fail to clip properly.Patient suffered blood loss as clips were failing (amount unknown), patient was fine.Surgery prolonged unsure how long.

Manufacturer Narrative

(b)(4).Batch #: unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances / manufacturing irregularities were identified.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.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.Additional information was requested, and the following was obtained: please clarify how the device ¿misfired".Did device not feed clips into the jaws? if it did feed clips, did it feed them sideways? did clips not advance fully into the jaws? did device not fire clips (jammed)? did device fire malformed clips? did device fire scissored clips? did device drop or eject clips? if other, please specify.Did clips not hold on to tissue or vessel once placed? was there any issue with bleeding? if yes, how was the bleeding controlled? what amount of blood loss (mls) occurred? was a transfusion required? was there any change to the procedure as a result of the event? what is the current patient status? the medium liga device fired malformed clips, they did not close fully and therefore did not stop the bleeding.A post op thyroidectomy patient was have difficultly with swelling and bleeding, the patient was brought back to theatre for a emergency follow up procedure.It was at this time that it was noted that the sites that were bleeding are where the liga clip had been used.Upon closed inspection it was identified that the clip was not closed and secure, and when removed not the expected shape for a fully closed clip.The bleeding was controlled via pressure and surgical sutures, diathermy was used to support.

Manufacturer Narrative

(b)(4).Date sent: 5/26/2022.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: describe more about the shape of the clip? was there any issue with device with regards to feeding and clip formation in the initial procedure? are there any pictures of the clips or device? what was the approximate blood loss and how was it treated?.

Manufacturer Narrative

(b)(4).Date sent: 7/6/2022.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 revealed that the mcm20 device was returned inside it's original packaging with a clip in the jaws and with no apparent damage.Upon testing, the instrument was cycled and it fed and formed 20 conforming clips; however, the clips were fed intermittently.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.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.

Manufacturer Narrative

(b)(4).Date sent: 8/18/2022 h6: type of investigation from b01 to b03 h6: component code from g07001 to g07002 h6: investigation conclusions from d5 to d14 h6: investigation findings from c07 to c19.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13934330
• MDR Text Key: 288352118
• Report Number: 3005075853-2022-01878
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCM20
• Device Catalogue Number: MCM20
• Device Lot Number: 582A27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention