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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330 MM HF ELECTRODES, RIGID

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OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330 MM HF ELECTRODES, RIGID Back to Search Results
Model Number A6282
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2020
Event Type  Malfunction  
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Brand NameHF-ELECTRODE, HOOK, 5 X 330 MM
Type of DeviceHF ELECTRODES, RIGID
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
Manufacturer (Section G)
BOWA-ELECTRONIC GMBH & CO KG
heinrich-hertz-strasse 4-10
gomaringen 72810
GM 72810
Manufacturer Contact
daniel wladow
kuehnstrasse 61
hamburg 22045
GM   22045
4940669662
MDR Report Key10405993
Report Number9610773-2020-00189
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK923982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Type of Report Initial
Report Date 08/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberA6282
Device Catalogue NumberA6282
Device LOT Number536461
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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