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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION HALL MICROPOWER + HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES

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CONMED CORPORATION HALL MICROPOWER + HIGH SPEED DRILL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7000SE
Device Problems Overheating of Device (1437); Excessive Heating (4030)
Patient Problem Burn(s) (1757)
Event Date 01/23/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant devices are as follows: pro7000se sn (b)(4). Pro7000se sn (b)(4). Pro7000se sn (b)(4). Pro7000se sn (b)(4). Pro7000se sn (b)(4). Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received. At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
On behalf of the customer in (b)(6), the conmed sales representative reported an issue with six (6) pro7000se, hall micropower + high speed drill. It was noted that "the drills are overheating bur guards and burning patients' lips. " additional clarification was obtained that indicated the conmed representative was told by the physician and the staff that the drills were heating up more than normal and had burned a patient's lip. No other information was provided to him. They requested the six (6) drills to be sent in and serviced for preventative precautionary measures. It was clarified that one (1) patient and one (1) device was involved in the reported burning of the lip. The reported date of event is an approximate date reported tot the conmed representative. As the facility did not identify which device was involved with the reported injury, and there was only one (1) reported burn, only one (1) incident/ device will be reported to the fda. The remaining five (5) devices will be listed as concomitant on this fda filing as they are being sent in for precautionary maintenance. This report is being raised as an injury due to the reported lip burn.
 
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Brand NameHALL MICROPOWER + HIGH SPEED DRILL
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd
largo, fl
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd
largo, fl
Manufacturer Contact
tracey weiselbenton
11311 concept blvd
largo, fl 
3995557
MDR Report Key9716868
MDR Text Key192460975
Report Number1017294-2020-00073
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPRO7000SE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/17/2020 Patient Sequence Number: 1
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