MAUDE Adverse Event Report: CONMED LARGO ERGO; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	D4240
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the d4240, ergo 2-button shaver handpiece was being used on (b)(6) 2025 during an unknown procedure when it was reported ¿handle heating up with use and causing error message.¿the procedure was completed with an alternate shaver device and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the d4240, ergo 2-button shaver handpiece was being used on (b)(6) 2025 during an unknown procedure when it was reported ¿handle heating up with use and causing error message.¿ the procedure was completed with an alternate shaver device and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of ¿handle heating up¿ was confirmed.Additional problems were found.The preventative maintenance was overdue.The motor and cable failed the high potential testing (hi pot).The gears seized.The repairs and the preventative maintenance were completed.The final test met all specifications.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be that the preventative maintenance was overdue.The service history was reviewed, and no prior data was found.A device history record (dhr) review found a non-conformance; however, it was not related to the manufacture of the product.A two-year review of complaint history revealed there has been a total of 22 complaints, regarding 22 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 that regular and proper maintenance of your equipment is the best way to protect your investment.It is essential that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time.The shaver handpieces shall be returned every 12 months for servicing.Continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: ERGO
• Common Device Name: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21171902
• Report Number: 1017294-2025-00006
• Device Sequence Number: 9494231
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)220330
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D4240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic