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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED MICROCHOICE OSC SAW

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CONMED MICROCHOICE OSC SAW Back to Search Results
Catalog Number 00502002400
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2017
Event Type  Injury  
Manufacturer Narrative
Despite several attempts to obtain the reported device, this device has not been returned to conmed for evaluation. Photographs were requested and, to date, none have been received. This incident cannot be verified and a root cause cannot be determined. The serial number provided was invalid, therefore, manufacturing documents were unable to be reviewed. A two-year review of complaint history revealed 7 similar reports for this product family. In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide. It is standard medical practice to inspect and test all equipment before use. This incident type will continue to be monitored through the complaint system to assure patient safety.
 
Manufacturer Narrative
The reported device is currently undergoing proper supply chain procedures but is expected to be returned to conmed for evaluation. A supplemental and final report will be filed after the device evaluation and complaint investigation are complete.
 
Event Description
The user facility reported that while the surgeon was using the oscillating handpiece the scrub nurse assembled, he noticed the blade was coming loose. When he pulled it out of the patients' mouth, during a multi-part oral reconstruction procedure, it was noted that multiple pieces of the device were detached. He retrieved parts of the device from the patients' mouth but when he tried to account for all pieces, two could not be located. A x-ray revealed one piece which the surgeon retrieved, however, the second piece was not accounted for. The surgeon performed a bronchoscopy to ensure the missing piece was not in the lungs. No patient injury was reported and the procedure was completed with more than a thirty minute delay. This report is raised on the basis of a device malfunction with an unlocated device component, which led to surgical intervention causing a lengthy procedural delay. This incident is being reported as an adverse event.
 
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Brand NameMICROCHOICE OSC SAW
Type of DeviceMICROCHOICE OSC SAW
Manufacturer (Section D)
CONMED
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED CORPORATION
525 french road
utica NY 13502
Manufacturer Contact
lindsey sheppard
525 french road
utica, NY 13502
7273995209
MDR Report Key6960758
MDR Text Key253244270
Report Number1017294-2017-00110
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K072706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number00502002400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
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