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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 Overheating of Device (1437)
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 handpiece overheated during surgery. A temporary impairment was reported; the malfunction caused a burn on the patient's lip. Additional information was not provided nor available. The adverse event 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 Key12319712
MDR Text Key266662192
Report Number9610612-2021-00566
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGD450M
Device Catalogue NumberGD450M
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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