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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number GB109
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 11/05/2020
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 to aesculap ag that a microline straight handpiece (part # gb109) was used during an oral surgery procedure performed on (b)(6) 2020. According to the complainant, the device generated heat when used in combination with another manufacturers bar. Reportedly, a large swollen burn occurred on the back of the patient's lips. The complaint device was available to be returned to the manufacturer for evaluation. Additional information was requested, but has not been made available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameMICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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 Key10952337
MDR Text Key252457319
Report Number9610612-2020-00854
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGB109
Device Catalogue NumberGB109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
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 Reuse

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