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

Catalog Number MCM20

Device Problem Defective Device (2588)

Patient Problems Cardiac Arrest (1762); Blood Loss (2597)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 device history records were reviewed and the manufacturing 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.What procedure was the device being used in? did the surgeon inspect the jaws of the device to check for clip placement prior to placing on the vessel? was proximal and distal control achieved? how many clips were placed prior to the failure of the device? how many successful clips were placed? what was the name of the vessel where the device was fired? did the clip or the device jaws cut the vessel? once the bleeding was identified intra-operatively, what was done to address it? how much blood was loss? did the patient arrest intra-operatively or were there post-op complications that led to the arrest? please explain.What is the current patient status?.

Event Description

It was reported that during a neck procedure patient in theatre having neck dissection.During the procedure the ethicon ligaclip failed to reload a vessel clamp, resulting in the jaws of the clipper slicing through a major vessel, the patient subsequently bled and arrested.Patient bled from major vessel and arrested, required further treatment.A new device from a different batch was opened and used to complete the surgery.The damages vessel was repaired.

Manufacturer Narrative

(b)(4).Batch #: r94e32.Device analysis: the analysis results found that the mcm20 device was returned with no damage in the external components.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 10 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8103073
• MDR Text Key: 128387866
• Report Number: 3005075853-2018-14570
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: MCM20
• Device Lot Number: R40R9N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/16/2019
• Patient Sequence Number: 1