MAUDE Adverse Event Report: CONMED CORPORATION HALL MICROPOWER+ HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7000SE

Device Problem Device Issue (2379)

Patient Problem Burn(s) (1757)

Event Date 05/26/2018

Event Type  Injury  

Manufacturer Narrative

The device was tested with a console and the testing found that the device temperature operated within specification.The device was found to be grinding and required part replacement.During conversation with the biomed technician at the facility he stated that he was not aware the handpiece would get hot.During conversation with the manager of the biomed it was found that the doctor had laid the handpiece on the lip of the patient during the procedure.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.The service history was reviewed and no data was found.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, 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: warnings: continually check handpiece for overheating.While handpiece is not in use do not place on patient/surgical drapes.Overheating can occur if bur guard bearings are worn or not kept clean.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the pro7000se, hall micropower+ high speed drill, was reported to have burned a patient during a tooth extraction on (b)(6) 2018.Through further research with the account it was found that the doctor laid the handpiece being used on the lip of the patient during the procedure.The facility stated that they were not aware that the handpiece could get hot.The ifu of the handpiece states that the user should continually check for overheating during use.The controller device, e9000, complaint (b)(4), has also had a complaint registered since it was involved in the procedure.There was no failure mode listed for the controller or the handpiece, only that they were involved with the patient burn.This report is being raised on the basis of injury due to the burn degree being unknown.

• Brand Name: HALL MICROPOWER+ HIGH SPEED DRILL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 7647843
• MDR Text Key: 112704010
• Report Number: 1017294-2018-00084
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 10845854040911
• UDI-Public: (01)10845854040911(11)180201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: PRO7000SE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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: 16 YR