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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG HI-LINE XXS DIAM.NEURO CUTTER III D3.0MM; TOOLS HIGHSPEED F/ HIGH SPEED POWER

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AESCULAP AG HI-LINE XXS DIAM.NEURO CUTTER III D3.0MM; TOOLS HIGHSPEED F/ HIGH SPEED POWER Back to Search Results
Model Number GE843SU
Device Problems Overheating of Device (1437); Detachment of Device or Device Component (2907); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: usa.It was reported by the surgeon, that while drilling, the tip of the burr spun off and burned through a drape.The incident occurred during surgery.Patient x-ray confirmed no drill parts remained in the patient.There was no harm to the patient reported.There was a five (5) minute or less delay in surgery.
 
Manufacturer Narrative
Investigation: the cutter has been analysed visually and microscopically.The diamond cutter at the fore side broke off.Tempering color of erratic appearance can be found at the foreside.Furthermore it can be found directly at the fracture surface.Batch history review: the device history records have been checked and found to be according to the specification, valid at the time of production.There is no indication of a material defect or a manufacturing failure.No further complaints registered against the same lot number.Conclusion and root cause: the failure is most probably usage related.Rational: after the investigation, the tempering color at the cutter indicates that the tool became hot during the operation.Therefore, we assume that an overload situation is combination with insufficient cooling may have led to the breakage due to a thermal stress.No capa is necessary.
 
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Brand Name
HI-LINE XXS DIAM.NEURO CUTTER III D3.0MM
Type of Device
TOOLS HIGHSPEED F/ HIGH SPEED POWER
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key7740905
MDR Text Key115764035
Report Number9610612-2018-00304
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGE843SU
Device Catalogue NumberGE843SU
Device Lot Number52332841
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2018
Distributor Facility Aware Date07/06/2018
Device Age14 MO
Initial Date Manufacturer Received 07/02/2018
Initial Date FDA Received08/01/2018
Supplement Dates Manufacturer Received07/02/2018
Supplement Dates FDA Received08/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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