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 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

The customer reported that the device, d4240, ergo 2-button shaver handpiece, was being tested during pre-op testing on an unknown date when it was reported, ¿the product overheats.¿.There was no report of injury, medical intervention, or hospitalization for the user and there was no patient involvement.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Event Description

The customer reported that the device, d4240, ergo 2-button shaver handpiece, was being tested during pre-op testing on an unknown date when it was reported, ¿the product overheats.¿.There was no report of injury, medical intervention, or hospitalization for the user and there was no patient involvement.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device was overdue for preventative maintenance.Additionally, the motor was seized and the cable was bad.The device was repaired, tested, and met all specifications.While a root cause cannot be identified, the likely cause of the event based on the ifu is that preventative maintenance was not performed in a timely fashion.A device history review (dhr) review was not conducted as the device has been in the field for greater than 12 months.The service history was reviewed and found similar repairs to this complaint.(b)(4).Per the instructions for use, the user is advised the following: failure to follow the specified service interval could result in reduced instrument performance or overheating of the handpiece.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 shaver handpieces shall be returned every 12 months for servicing.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: 18719795
• MDR Text Key: 336620577
• Report Number: 1017294-2024-00022
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)170405(30)1
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D4240
• Device Lot Number: LAA11058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic