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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MICRO FLEXIBLE CABLE 2.3M HIGH SPEED POWER SYSTEMS

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AESCULAP AG MICRO FLEXIBLE CABLE 2.3M HIGH SPEED POWER SYSTEMS Back to Search Results
Model Number GA173
Device Problem Excessive Heating (4030)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 08/10/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Pending further information.
 
Event Description
It was reported by the healthcare professional to the company sales representative "during an ambulatory dental surgery the patient received a second degree burn to the wrist due to a cable overheating that was placed on the patient. It was also reported the cable will be returned. Additional information received reported the patient went home the day of the surgery and declared nothing. The patient declared the burn after and he treated himself. He came back at the end of the week with normal healing.
 
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Brand NameMICRO FLEXIBLE CABLE 2.3M
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 Key7915120
MDR Text Key121912792
Report Number9610612-2018-00430
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K953968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGA173
Device Catalogue NumberGA173
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/05/2018
Event Location No Information
Date Manufacturer Received10/22/2018
Was Device Evaluated by Manufacturer? Yes
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: 09/27/2018 Patient Sequence Number: 1
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