MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM; POWER SYSTEMS

Model Number GD455M

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/01/2022

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 gd455m - micro-line angled hdpc 1:2 f/2.35x70mm.According to the complaint description, when removing wisdom teeth, the handpiece became very hot during use and burned the inside of the patient's cheek.Fortunately, the burn was superficial but caused some pain.There was temporary impairment.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: the product was sent to aesculap technical department for investigation.Due to the long use since 2014, the product has been worn out accordingly and is in poor condition.The adhesive connection has probably loosened after long use.Therefore, the tip and ball bearing were damaged.Further evaluation was performed in the qm department.The investigation was carried out visually and microscopically.We made a visual inspection of the product.We detected that the ball bearing was broken.Additionally, the tip and the handpiece was with residues, and we detected corrosion on the inside of the handpiece.Therefore, we recommend that the product is maintained at least once a year.Additionally, there is risk of burns caused by blunt tools or inadequacy of maintenance of the handpiece.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 6(10) x probability of occurrence 3(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based on the investigation results, the root cause of the problem is most probably reprocessing-related.Based on the investigation results, a capa is not required.

• Brand Name: MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM
• Type of Device: 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: 13826697
• MDR Text Key: 288621424
• Report Number: 9610612-2022-00070
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD455M
• Device Catalogue Number: GD455M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• 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