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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 Problems Break (1069); Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 09/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: a functional test could not be conducted. The collet could not be opened. The failure of the device was caused by a broken bearing. Despite the broken bearing, the hand piece was used. The tip of the hand piece became too hot, damaged the distal end, and burnt the patient. The mounting pin for the attachment of a component is pressed in, and the welding seams are broken. Based on the information available as well as a result of the investigation, root cause of the failure is most probably user related and related to an insufficient maintenance of the device. Corrective preventive action is not required. The current failure is within the risk analysis and therefore acceptable.
 
Event Description
Country of complaint: (b)(6). It is reported that a patient was burned by a device, and as a result has 2nd degree burns on the left side of the lower lip.
 
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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 Key6048474
MDR Text Key58135630
Report Number2916714-2016-00875
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
Report Date 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2016
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 Manufacturer09/26/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date10/10/2016
Device Age3 YR
Event Location No Information
Date Manufacturer Received10/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
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: 10/21/2016 Patient Sequence Number: 1
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