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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

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 Description

A customer reported on (b)(6) 2024 regarding the d4240, ergo 2-button shaver handpiece, stating ¿prev maint, gets hot, no patient injury¿.This non-surgical event had no impact on a patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

A customer reported on 27feb24 regarding the d4240, ergo 2-button shaver handpiece, stating ¿prev maint, gets hot, no patient injury¿.This non-surgical event had no impact on a patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: the spelling of the initial reporter's last name has been corrected in section e.1.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history was reviewed and no relationship to this complaint was found.A device history review (dhr) review was not conducted as the device has been in the field for greater than 12 months.A two-year review of complaint history revealed there has been a total of 18 reports, regarding 18 devices, for this device family and failure mode.During this same time frame 3,105 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 0.006.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, and overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

Device evaluation: the device was not overdue for preventative maintenance.No fault was found with the device.The device was tested and met all specifications.The service history was reviewed and no relationship to this complaint was found.A device history review (dhr) review was not conducted as the device has been in the field for greater than 12 months.(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, and overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

A customer reported on (b)(6) 2024 regarding the d4240, ergo 2-button shaver handpiece, stating "prev maint, gets hot, no patient injury".This non-surgical event had no impact on a patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18885181
• MDR Text Key: 337425147
• Report Number: 1017294-2024-00027
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D4240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic