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	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, d4240, ergo 2-button shaver handpiece, was being used during a knee arthroscopy procedure on (b)(6) 2024 when it was reported, ¿got very hot during the case to the point the doctor said it was burning his hand.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment information found that the user was not burned, only that the device got hot.The procedure was completed with another shaver causing a 2-minute delay.The patient was reported as being ¿fine¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, d4240, ergo 2-button shaver handpiece, was being used during a knee arthroscopy procedure on (b)(6) 2024 when it was reported, ¿got very hot during the case to the point the doctor said it was burning his hand.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment information found that the user was not burned, only that the device got hot.The procedure was completed with another shaver causing a 2-minute delay.The patient was reported as being ¿fine¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The evaluation found that the motor needs replacing.The unit was tested at 6000 rpm for 5 minutes and the motor temperature exceeded 110 degrees f.The motor was replaced, and the unit tested again under the same conditions.The unit runs at an operational 101 degrees f maximum.No preventative maintenance was necessary as it was not overdue.A 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 found similar repairs to this complaint.A two-year review of complaint history revealed there has been a total of 20 complaints, regarding 20 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 to 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.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.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 19870909
• Report Number: 1017294-2024-00091
• Device Sequence Number: 7254782
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)230118
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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
• Date Returned to Manufacturer: 07/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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