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

Catalog Number MCS20

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 01/24/2018

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.A manufacturing record evaluation was performed for the finished device lot number r4189z, and no non-conformances were identified.Additional information was requested, but unavailable: how did the alleged deficiency of the clip applier make the ima unsuitable for bypass? where were the clips being used on the ima? was there anything unusual noted during the firing of the device (higher force to fire or lower force to fire)? did the surgeon confirm that there was a clip in the jaw prior to placing it on the vessel? please describe the clip formation that may have led to the vessel damage.Was other medical intervention required? if yes, please explain what this intervention was.Was the patients post-operative care altered in any way due to the issue that was reported?.

Event Description

It was reported that the cv surgeon was using the mcs20 clip applier on and around the ima for use on bypass.The clip applier malfunctioned and fired two clips and cut the vessel, making it not available to use for jump, doctor had to then use saphenous vein (incision on the leg) for conduit vessel.The surgery was delayed for 1-hour.

Manufacturer Narrative

(b)(4).Batch # r9557p.Additional information received: mw5083830.Per maude report: physician using a prepackaged small clip applier to prepare mammary artery for grafting.Applier misfired, used two clips and did not close but perforated mammary artery and made it unusable.Device analysis: the analysis results found that the mcs20 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 12 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.A manufacturing record evaluation was performed for the finished device batch number r9557p, 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: 8361389
• MDR Text Key: 136857715
• Report Number: 3005075853-2019-16769
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 11/30/2023
• Device Catalogue Number: MCS20
• Device Lot Number: R4189Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/06/2019
• Patient Sequence Number: 1