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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, UNIPOLAR, ANGLED
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KARL STORZ SE & CO. KG ELECTRODE, UNIPOLAR, ANGLED Back to Search Results
Model Number 011110-10
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the angled unipolar electrode broke during the resection of the tumor.No additional information was provided.
 
Manufacturer Narrative
Attempts to obtain more information and reported device were made; however, the reporter has not responded to the request.Once new information is received or the reported device is returned for evaluation, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
ELECTRODE, UNIPOLAR, ANGLED
Type of Device
ELECTRODE, UNIPOLAR, ANGLED
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM   78532
Manufacturer Contact
anja fair
2151 e grand ave.
el segundo, CA 90245
MDR Report Key18851513
MDR Text Key337069479
Report Number9610617-2024-00053
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K882270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number011110-10
Device Catalogue Number011110-10
Date Manufacturer Received02/12/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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