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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO ERGO 2-BUTTON SHAVER HANDPIECE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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CONMED LARGO ERGO 2-BUTTON SHAVER HANDPIECE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number D4240
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
The customer reported that the device, d4240, ergo 2-button shaver handpiece, had been used in an unknown procedure on approximately 7mar24 when it was reported, ¿keeps getting hot, no patient impact.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Manufacturer Narrative
An evaluation of the returned device found that the unit cable fails ground bond.The unit was repaired, evaluation completed and final tested.The unit met all specifications.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be component failure.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.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 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).Per the instructions for use, the user is advised the following: continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Event Description
The customer reported that the device, d4240, ergo 2-button shaver handpiece, had been used in an unknown procedure on approximately 7mar24 when it was reported, ¿keeps getting hot, no patient impact.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
 
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Brand Name
ERGO 2-BUTTON SHAVER HANDPIECE
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer Contact
john berga
11311 concept blvd
largo, FL 33773
7273995358
MDR Report Key18939236
MDR Text Key338091850
Report Number1017294-2024-00033
Device Sequence Number1
Product Code GEY
UDI-Device Identifier10845854013144
UDI-Public(01)10845854013144(11)211027
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD4240
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2021
Is the Device Single Use? No
Patient Sequence Number1
Patient EthnicityNon Hispanic
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