MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM; HIGHSPEED POWER SYSTEMS

Model Number GD450M

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with gd450m - micro-line straight hdpc 1:1 f/2.35x70mm.According to the complaint description, the customer account a lot of problem with the handpiece some of them provoked burns because of overheating.Error description: it is an maxillofacial osteotomy and not an genioplasty additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00033 (400499625 +gd450m), 9610612-2021-00035 (400499629 + gd450r), 9610612-2021-00036 (400499630 + gd450r), 9610612-2021-00032 (400499624 + gd450m).

Manufacturer Narrative

Investigation results: visual investigation: the parts have been visually and functionally checked.The handpiece is in very poor condition.Loud running noises could be detected.The interior is soiled and heavy corrosion could be found.As a result, the ball bearing in the shaft is broken and the collet is jammed.The tip can no longer be disassembled.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 3(5) probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.Associated medwatch-reports: 9610612-2021-00033 (b)(4), 9610612-2021-00034 (b)(4), 9610612-2021-00035 (b)(4), 9610612-2021-00036 (b)(4), 9610612-2021-00032 (b)(4).

Event Description

The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11287634
• MDR Text Key: 239100760
• Report Number: 9610612-2021-00034
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: A883357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD450M
• Device Catalogue Number: GD450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other