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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO HALL MICROPOWER+ HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES
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CONMED LARGO HALL MICROPOWER+ HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7000SE
Device Problem Unintended Ejection (1234)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The sales representative reported on behalf of the customer that pro7000se, hall micropower+ high speed drill was being used on an unknown date during an unknown procedure when it was reported ¿the bur wasn¿t locking into the handpiece, once i went into the account and saw what was going on, it¿s clear that something inside the handpiece itself is cutting the burs in half and causing them to eject out of the handpiece.¿ further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
The reported device is being 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.
 
Manufacturer Narrative
The reported event of ¿bur not locking into hand piece¿ is not confirmed.Evaluation of the device found collet bearing failure and the cast stator failed ground bond test.Additionally, the pm is overdue.The service history was reviewed, and no previous service data was found.A device history review was not conducted as the device has been in the field more than 12 months.(b)(4).Per the instructions for use, the user is advised the following: to ensure all accessories are correctly and completely attached and to perform the required preoperative functional tests for the equipment and accessories prior to each use.The ifu also advises the user that it is essential that the equipment be serviced as scheduled to retain optimum performance and reliability; the micropower+ handpieces shall be returned every 12 months for servicing.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 pro7000se, hall micropower+ high speed drill was being used on an unknown date during an unknown procedure when it was reported ¿the bur wasn¿t locking into the handpiece, once i went into the account and saw what was going on, it¿s clear that something inside the handpiece itself is cutting the burs in half and causing them to eject out of the handpiece.¿ further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand Name
HALL MICROPOWER+ HIGH SPEED DRILL
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer Contact
samantha dewberry
525 french road
utica, NY 13502
3152230184
MDR Report Key15745520
MDR Text Key307592971
Report Number1017294-2022-00106
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPRO7000SE
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received12/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient EthnicityNon Hispanic
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