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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG HF COMBI UNIT 300W MONOP.80W.BIPOLAR ENDOSCOPY

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AESCULAP AG HF COMBI UNIT 300W MONOP.80W.BIPOLAR ENDOSCOPY Back to Search Results
Model Number GN300
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
We sent the device to the generator manufacturing for analysis. They tested the device at the end of line test and compared the results with the archived eol test results of this serial number before delivery. During the performance test, the generator is connected with different dummy loads at the output and it has to work with different supply voltages. The number of generators per batch is one. The eol test files are within specification. The root cause for the problem is most probably user related. The complaint rf generator has past all tests (power, resistance, safety) without any deviation. According to (b)(4) there is no capa necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that the device had extreme burning issues.
 
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Brand NameHF COMBI UNIT 300W MONOP.80W.BIPOLAR
Type of DeviceENDOSCOPY
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 Key6437603
MDR Text Key192360863
Report Number9610612-2017-00151
Device Sequence Number1
Product Code KPZ
Combination Product (y/n)N
Reporter Country CodeTU
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 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGN300
Device Catalogue NumberGN300
Device Lot Number52187002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/09/2017
Device Age15 MO
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2015
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: 03/27/2017 Patient Sequence Number: 1
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