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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
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KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE Back to Search Results
Model Number 011160-01
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
It was reported that two electrodes broke during a hysteroscopy.The surgical delay was less than 15 minutes.No negative impact in state of health reported.
 
Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
ELECTRODE, BIPOLAR
Type of Device
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
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 Key18810627
MDR Text Key337632885
Report Number9610617-2024-00050
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K221893
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
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number011160-01
Device Catalogue Number011160-01
Device Lot NumberZN62
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2024
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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