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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 HIGH SPEED POWER SYSTEMS

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AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT HIGH SPEED POWER SYSTEMS Back to Search Results
Model Number GB109
Device Problem Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 12/22/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation was carried out by ats (b)(4). The dowel pin of the housing is missing. Untypical noises and vibrations during a function test. Under load, the hand piece becomes quickly very hot. The front ball bearing is broken and the inside of the housing is soiled. The mounted tool is loose. The nozzle is broken. A review of the device quality and manufacturing history records was not possible because the device is a purchased part. Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient maintenance of the device. According to (b)(4) a capa is not necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). During the extraction of a wisdom tooth, the patient received 2nd degree burns.
 
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Brand NameMICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT
Type of DeviceHIGH SPEED 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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6263713
MDR Text Key161885647
Report Number9610612-2017-00032
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
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 Manufacturer01/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/09/2017
Device Age2 YR
Event Location No Information
Date Manufacturer Received12/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2017 Patient Sequence Number: 1
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