MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® HANDPIECE - STYLUS TOUCH®; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number EM210

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that pre-operative, the handpiece had overheating issue.No patient involved.

Manufacturer Narrative

H3: product analysis: visually the cosmetic condition of product okay.Not able to confirm the reported fault, because the the temperature test was not able to performed due to the tool was not locking in the attachment.The hi-pot test passed, dept test failed and the handpiece was corroded.The facility name is not provided to the manufacturer, follow-up is being performed to the sales rep.Supplemental rr will be submitted once the facility information is received.A follow-up report will be submitted when any additional findings are received.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: IPC® HANDPIECE - STYLUS TOUCH®
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 18948374
• MDR Text Key: 338460720
• Report Number: 1045254-2024-00395
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

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
• Device Operator: Health Professional
• Device Model Number: EM210
• Device Catalogue Number: EM210
• Device Lot Number: 216074849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1