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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM HIGHSPEED POWER SYSTEMS

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AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM HIGHSPEED POWER SYSTEMS Back to Search Results
Model Number GD450M
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
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 that there was an issue with gd450m - micro-line straight hdpc 1:1 f/2. 35x70mm. According to the complaint description, the patient has received a burn to the mouth/lip from a gd450m hand piece. Drill was used with round bur. Bur shank was not in contact with oral soft tissues at any point. Bowdler henry rake retractor used to retract tissues. Plastic cheek retractor (not routinely used in oral surgery) not used as would impede access to the necessary site. The handpiece overheated rapidly and the surgeon let go of the drill immediately. The scrub team were informed. It was not until a few minutes later that the surgeon noticed a partial thickness burn to the upper left lip involving the wet and dry lip mucosa. The area was immediately flooded with cold water and cool gauze placed. The area was cooled multiple times thereafter. Hydrocortisone 1% ointment was applied with injection of 0. 5% marcaine with adrenaline. There was temporary impairment. Additional patient information is not available. The malfunction is filed under aag reference (b)(4). Involved components gd460r - spray nozzle for gd450r/gd455r/gd465 - lot unknown. Ga824 - elan 4 electro low speed motor intra - lot unknown. Ga806 - elan 4 electro motor cable f/foot ctrl. - lot unknown. Gd460r - spray nozzle for gd450r/gd455r/gd465 - lot unknown. Ga824 - elan 4 electro low speed motor intra - lot unknown. Ga806 - elan 4 electro motor cable f/foot ctrl. - lot unknown.
 
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Brand NameMICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
Type of DeviceHIGHSPEED 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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key12519900
MDR Text Key272937915
Report Number9610612-2021-00643
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGD450M
Device Catalogue NumberGD450M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
Treatment
GA806 - LOT UNKNOWN; GA806 - LOT UNKNOWN; GA824 - LOT UNKNOWN; GA824 - LOT UNKNOWN; GD460R - LOT UNKNOWN; GD460R - LOT UNKNOWN
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