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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA SMALL APPLIER; CLIP, IMPLANTABLE Back to Search Results
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.
 
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Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key8361389
MDR Text Key136857715
Report Number3005075853-2019-16769
Device Sequence Number1
Product Code GDO
UDI-Device Identifier10705036002499
UDI-Public10705036002499
Combination Product (y/n)N
PMA/PMN Number
K820837
Number of Events Reported1
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 Date11/30/2023
Device Catalogue NumberMCS20
Device Lot NumberR4189Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Initial Date Manufacturer Received 01/30/2019
Initial Date FDA Received02/22/2019
Supplement Dates Manufacturer Received02/25/2019
Supplement Dates FDA Received03/06/2019
Patient Sequence Number1
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