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U.S. Department of Health and Human Services

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

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AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM HIGHSPEED POWER SYSTEMS Back to Search Results
Model Number GD450M
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
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, 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).
 
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Brand NameMICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
Type of DeviceHIGHSPEED 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 Key12253745
MDR Text Key264331329
Report Number9610612-2021-00525
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGD450M
Device Catalogue NumberGD450M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2021
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 Unkown

Patient Treatment Data
Date Received: 07/30/2021 Patient Sequence Number: 1
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