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

Model Number	GD450M
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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, when the drill was activated, oil or water came out of the tip and dripped into the patient's mouth.The doctor used saline solution to rinse the patient's mouth right away, and another tray was used to continue surgery.The malfunction prolonged the surgery and required medical intervention.This occurred during a le fort procedure.Additional information was not provided.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Visual investigation: the investigation has been carried-out by the aesculap technical service (ats).The handpiece has been checked according to the internal inspection plan.The technical employee noted that the inner of the handpiece is with corrosion.Furthermore, by functional testing, there are loud running noises.Additionally, the product investigation carried out by the investigator from the qm department.The vigilance investigator carried out the pictorial documentation visually with "panasonic dmc tz8" and microscopically.The surface of the inner pieces of the product are with residues and corrosion.The ball bearing and the shaft driver was worn out and damaged due to corrosion.The state of the interior points to inadequate and incorrect reprocessing.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.Conclusion and measures / preventive measures: upon the investigation results the root cause of the problem is mostly reprocessing related.The instructions for use (ifu) should be taken into account to prevent such errors in the future.Based upon the investigations results a capa is not necessary.

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
• Common Device Name: 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: 12253745
• Report Number: 9610612-2021-00525
• Device Sequence Number: 4066527
• Product Code: HWE
• UDI-Device Identifier: 04038653444885
• UDI-Public: 4038653444885
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GD450M
• Device Catalogue Number: GD450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown