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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED MICROPOWER OSCILLATOR SAW, DETACHABLE LEVER DRILL/SAW HANDPIECE, ELECTRIC

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CONMED MICROPOWER OSCILLATOR SAW, DETACHABLE LEVER DRILL/SAW HANDPIECE, ELECTRIC Back to Search Results
Catalog Number 00602002400
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
The reported device was returned to conmed for evaluation. The collet top was observed to be broken, the cast stator was blistering inside and rotor bearing was worn. This device should be serviced every 12 months; however, this device does not have a service history with conmed. A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue. A two-year historical complaint review revealed no prior complaints related to this failure for this device. In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide. A risk analysis was performed and this failure is deemed acceptable. The customer is advised of the following warning and precautions set forth in the instructions for use. -inspect all medical equipment before use. -preventative maintenance should be completed every 12-months. Service intervals are required to keep the equipment at its optimum operating performance. This incident type will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
A biomedical hospital engineer reported while the doctor was using a micropower oscillator saw during a dental procedure, the head broke apart. It was reported pieces were left inside the patient, however, fragments were found inside the suction container and an x-ray did not confirm this claim. The procedure was completed with a 30-minute surgical delay and using an alternative device. The patient has recovered as expected. This report is raised on the basis of a reported device detachment that has the potential to adversely affect a patient. This report is classified as an injury due to fragments potentially being not retrieved.
 
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Brand NameMICROPOWER OSCILLATOR SAW, DETACHABLE LEVER
Type of DeviceDRILL/SAW HANDPIECE, ELECTRIC
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 Key7167441
MDR Text Key96472347
Report Number1017294-2017-00150
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00602002400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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