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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 Fluid Leak (1250); Overheating of Device (1437)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that during an osteotomy surgery, there was a popping noise, and black oil came out of the proximal tip of the hand piece. The surgeon stopped the procedure. The patient was burned at the commissure of the labial. Component in use listed as concomitant device is: gb109 / micro-line straight hdpc 1:1 round shaft. Gd672 / microspeed uni motor cable f/foot ctrl. Gd678 / microspeed uni micro 150 motor. Gd670 / microspeed uni control unit w/cool. Unit.
 
Manufacturer Narrative
Investigation: gb109 - 400309978: the hand piece was build in 2013 and never sent in for maintenance. The device is without function and can not be mounted to the engine because the connection part is damaged. Most likely the hand piece was not mounted correctly to the engine several times. Thus the hand piece turned around when starting the engine and damaged the surface inside the connection part. The collet is dirty, rusty and can no longer be opened. The front bearing is broken. In the whole inner room residues are recognizable. The spray nozzle is bent, deformed and torn. A repair is not possible. Gd672 - 400309979: the cable was build in 2010 and never sent in for maintenance. The insulation is porous and has become shorter in the course of the years due to wear and tear. Despite the damage, the cable passed the insulation test but must be replaced for safety reasons. On the housing (gd672401) and flaps (gd673420) rust can be recognized. Gd678 - 400309980: the engine was build at 20. 01. 2014 and never sent in for maintenance. As already mentioned at the hand piece, the surface is damaged due to incorrect mounted counter part. In the inner room residues and rust, due to an inadequate maintenance, can be found. The stator is swollen and has to be exchanged. This can also be attributed to the inadequate maintenance. Gd670 - 400309981: the product is not available for investigation. Batch history review: a review of the device quality and manufacturing history records was not possible because the device is a purchased part. Conclusion and root cause: 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. Corrective action: according to sop sa-de13-m-4-2-01-010 a capa is not necessary.
 
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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 Key5908689
MDR Text Key53277890
Report Number2916714-2016-00663
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 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
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 Manufacturer08/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/02/2016
Device Age3 YR
Event Location No Information
Date Manufacturer Received07/29/2016
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: 08/26/2016 Patient Sequence Number: 1
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