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

Catalog Number MCM20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: can you please clarify how the severed vessel was addressed? oversewn with suture.How was the procedure completed? as normal.Were there any patient consequences? graft/flap did not take so having to reattempt another graft today.Were there any changes in the post-operative care of the patient? patient was taken to theatre on 2 different occasions to perform a reanastomosis.Additional follow-up was conducted, and the following information was received: did the jaws of the jaws of the device cut the vessel or did the clip cut the vessel? unsure all happened during firing sequence.Did the surgeon believe that the re-attempt for the graft is associated with the alleged deficiency of the clip applier? if yes, please explain why.Couldn¿t enough length of vessel so when graft was transferred it didn¿t have sufficient supply.Also feels graft may have died due to time sorting bleed.What was the approximate size of the vessels that the mcm20 was fired on? 5-7mm.Is it the surgeons normal routing to check the jaws of the device to ensure that there is a clip in the jaw prior to firing? yes, however can¿t guarantee clip was there.Please provide the status of the device as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Device was not kept to be sent back.

Event Description

It was reported that during a free flap reconstruction, the clip applier severed vessel instead of clipping it.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number r41649, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8469444
• MDR Text Key: 140528286
• Report Number: 3005075853-2019-17701
• 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
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: MCM20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• Patient Sequence Number: 1