MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC HANDPIECE - INDIGO DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number 1845000

Device Problems Break (1069); Overheating of Device (1437); Use of Device Problem (1670)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The product analysis result indicates that error code 11 (unrecognized/damaged handpiece port displayed when plugged in.The cable failure was causing the problem and has been replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a health care professional that the handpiece was broken.There was no patient impact.Upon follow up it was stated that the drill was connected to the console and after a short time of work, then the drill overheated.No external damage could be seen.There was no troubleshooting performed, because it wasn`t possible.The drill did not work again.

• Brand Name: IPC HANDPIECE - INDIGO DRILL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: tricha miles ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635140379
• MDR Report Key: 11071695
• MDR Text Key: 223607959
• Report Number: 1045254-2020-00643
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00613994933713
• UDI-Public: 00613994933713
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/24/2020

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: 1845000
• Device Catalogue Number: 1845000
• Device Lot Number: 206496451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2013
• 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