MAUDE Adverse Event Report: CONMED LARGO ERGO 2-BUTTON SHAVER HANDPIECE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number D4240

Device Problem Overheating of Device (1437)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Evaluation found the motor seized and the pcb won¿t turn on or off.Additionally, the preventive maintenance (pm) was overdue.A device history record review was not performed as the device has been in the field for more than 12 months.The service history was reviewed, and no previous service data was found.At the time of the event, the device was 17 months of age.A two-year review of complaint history revealed there has been a total of two complaints, regarding two 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 0.0009.Per the instructions for use, the user is advised to continually check the hand piece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.The ifu also advises the user that failure to follow the specified service interval could result in reduce instrument performance or overheating of the hand piece.Overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.The recommended service interval for this device is 12 months.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, d4240, was being used during an operative arthroscopy of the knee joint on (b)(6) 2021 when it was reported ¿burn of the patient by shaver ergo d4240.After connecting the shaver to the control console, before use, the shaver was put on the patient's body in the pubic area, covered with a drape, the shaver in the ready state with the blade attached before activation automatically heated up to a high temperature, as a result of which the patient's body was burned in the pubic area -burn of the first and second degree.¿ the procedure was completed with another company¿s shaver.Further assessment information was requested; however, to date a response has not been received.This report is being raised on the basis of injury due to a report of first and second degree burns being sustained by the patient.

• 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 Key: 12409822
• MDR Text Key: 274797910
• Report Number: 1017294-2021-00332
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K050519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D4240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR