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

Model Number GD450M

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

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 drill was getting hot.The customer replied saying that he don't like this new drill as they are longer than the old ones.It was explained that the length of the drill head is the same as the old ones and the only different with the new drill is the motor.At that point it was noticed that the drill had some tissues, so staff looked inside the patients' mouth.It was noted that there was a mark on the patients' right inner cheek and lips.There was a temporary impairment (no burn was observed).This malfunction occurred during extraction of three wisdom teeth.Additional information was not provided nor available / was not available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: optically, the products are in a used but good condition.The handpiece has been checked according to the internal inspection plan.A visual and function check (e.G.Plug connection, current consumption, temperature, running noises) was performed.The plug connection is damaged and deformed.It was not possible to insert the gauge.However, a heating could not be detected.Quiet and smooth working.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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.

• 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11821479
• MDR Text Key: 262692865
• Report Number: 9610612-2021-00387
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• 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: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1