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

Catalog Number	D4240
Medical Device Problem Codes	Noise, Audible (3273); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
It was reported that the d4240 ergo 2-button shaver handpiece, device was found on an unknown date during pre-operative testing when it was reported ¿heat and noisy.¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device was not overdue for preventative maintenance.Additionally, the motor failed the hi pot test, the gears were seized/binding/grinding and the cable jacket had damage.The device was repaired, tested, and met all specifications.While a root cause cannot be identified, the likely cause of the event based the device evaluation and the ifu is that user used excessive force and continued to use the device even though the device should have been returned for repair at the first indication of damage.The service history was reviewed and found similar repairs to this complaint.A device history review (dhr) review found no abnormalities that would contribute to this reported event.A two-year review complaint history revealed there has been a total of 18 complaints, regarding 18 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 excessively bend or kink the handpiece cord.Always inspect cords for signs of excessive wear or damage, or bent, broken or missing pins within the connector(s).If any wear or damage is found, discontinue use and replace handpiece immediately.Using a damaged power cord could possibly cause injury.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
It was reported that the d4240 ergo 2-button shaver handpiece, device was found on an unknown date during pre-operative testing when it was reported ¿heat and noisy.¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 20138427
• Report Number: 1017294-2024-00102
• Device Sequence Number: 7462466
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)180829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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
• Device Lot Number: LAA12946
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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