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	11/27/2024
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.H3 other text : device not yet received.
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 approximately (b)(6) 2024 during a shoulder arthroscopy and the device ¿got really hot on the surgeon's hand and shut off.¿.There was no report of impact or injury to the patient or user."nobody was injured.The doctor said he felt it getting hot in is hand and stoppped using it and asked for another shaver handpiece.".The procedure was completed with a delay of a "few minutes to garb another shaver handpiece".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 approximately (b)(6)2024 during a shoulder arthroscopy and the device ¿got really hot on the surgeon's hand and shut off.¿.There was no report of impact or injury to the patient or user."nobody was injured.The doctor said he felt it getting hot in is hand and stoppped using it and asked for another shaver handpiece.".The procedure was completed with a delay of a "few minutes to garb another shaver handpiece".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the device found motor ¿ fails hi pot and gears ¿ seized / binding / grinding.Repair/evaluation completed.Final test completed and met all specifications.Root cause cannot be determined, however, based upon ifu.; a possible cause of this event could be excessive force.The service history was reviewed and found similar repairs to this complaint.A device history record (dhr) review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 19 reports, regarding 19 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.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.Running the shaver blade or bur without fluid flow (dry) may cause damage to the handpiece or may cause the bur hubs to melt due to excessive heat.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.Run the handpiece for less than 5 seconds at a speed less than 1500 rpm to observe any abnormal noises, vibrations or heat rise.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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20901419
• Report Number: 1017294-2024-00147
• Device Sequence Number: 8948670
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)170405(30)1
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2017
• 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