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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO MICROCHOICE REPEAT STERNOTOMY BLADE 54.6MM 5 EA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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CONMED LARGO MICROCHOICE REPEAT STERNOTOMY BLADE 54.6MM 5 EA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Catalog Number 00502317900
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Hypoxia (1918); Hypovolemia (2243); Insufficient Information (4580)
Event Date 11/10/2021
Event Type  Death  
Event Description
The sales representative reported on behalf of the customer that the device, (b)(4), microchoice repeat sternotomy blade, was being used on 10nov21 during an aortic valve replacement procedure and in a primary sternotomy the surgeon preferred to use a repeat sternotomy blade.During the sternum cut he accidentally cut the aorta artery.The procedure was not completed as during the sternotomy the dr.Accidentally cut the aorta artery.There was a delay of an hour and a half.The last status update reported the female patient as still in intensive care and unconscious.After further assessment it was found, the procedure was completed with the help of the chief of cardiac surgery and other vascular surgeons.A status update was requested; however, no response has been received to date.The pro9100b hall titan single trigger battery handpiece, (b)(4), hall large lithium battery and the pro2043, powerpro sagittal saw attachment will be listed as concomitant devices.This report is being raised on the basis of injury due to cutting of the aortic artery.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The sales representative reported on behalf of the customer that the device, 00502317900, microchoice repeat sternotomy blade, was being used on (b)(6) 2021 during an aortic valve replacement procedure and in a primary sternotomy the surgeon preferred to use a repeat sternotomy blade.During the sternum cut he accidentally cut the aorta artery.The procedure was not completed as during the sternotomy the dr.Accidentally cut the aorta artery.There was a delay of an hour and a half.The last status update reported the female patient as still in intensive care and unconscious.After further assessment it was found, the procedure was completed with the help of the chief of cardiac surgery and other vascular surgeons.A status update was requested; however, no response has been received to date.The pro9100b hall titan single trigger battery handpiece, l3000lg, hall large lithium battery and the pro2043, powerpro sagittal saw attachment will be listed as concomitant devices.This report is being raised on the basis of injury due to cutting of the aortic artery.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Manufacturer Narrative
Reported event of blade being ¿too sharp¿ is inconclusive.The device was not returned for evaluation and no photographic evidence was provided.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
Update: further information was received on 25jan22.After the aorta was cut on (b)(6) 2021, the patient experienced massive hemorrhage with consequent hypovolemia and a few minutes of cerebral hypoxia.The doctors were able to stabilize the patient at that time.The female patient died on (b)(6) 2022.It was also noted that this was a revision sternotomy.The sales representative reported on behalf of the customer that the device, 00502317900, microchoice repeat sternotomy blade, was being used on (b)(6) 2021 during an aortic valve replacement procedure and in a primary sternotomy the surgeon preferred to use a repeat sternotomy blade.During the sternum cut he accidentally cut the aorta artery.The procedure was not completed as during the sternotomy the dr.Accidentally cut the aorta artery.There was a delay of an hour and a half.The last status update reported the female patient as still in intensive care and unconscious.After further assessment it was found, the procedure was completed with the help of the chief of cardiac surgery and other vascular surgeons.A status update was requested; however, no response has been received to date.The pro9100b hall titan single trigger battery handpiece, l3000lg, hall large lithium battery and the pro2043, powerpro sagittal saw attachment will be listed as concomitant devices.This report is being raised on the basis of death due to cutting of the aortic artery.
 
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Brand Name
MICROCHOICE REPEAT STERNOTOMY BLADE 54.6MM 5 EA
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer Contact
robin drum
11311 concept blvd
largo, FL 33773
8653881978
MDR Report Key12923822
MDR Text Key285226396
Report Number1017294-2021-00364
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/18/2022
Device Catalogue Number00502317900
Device Lot Number858866
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2017
Is the Device Single Use? Yes
Patient Sequence Number1
Treatment
L3000LG HALL BATTERY; L3000LG HALL BATTERY; PRO2043 SAW ATTACHMENT; PRO2043 SAW ATTACHMENT; PRO9100B HALL BATTERY HANDPIECE; PRO9100B HALL BATTERY HANDPIECE
Patient Outcome(s) Death; Life Threatening; Other; Required Intervention;
Patient SexFemale
Patient EthnicityNon Hispanic
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