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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UROLOGY INNER SHEATH; INNER RESECTOSCOPE SHEATH
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KARL STORZ SE & CO. KG UROLOGY INNER SHEATH; INNER RESECTOSCOPE SHEATH Back to Search Results
Model Number 27050CA
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Event Description
Per facility during a procedure the distal ceramic tip of the inner sheath broke off inside the patient.The broken piece was retrieved.No additional information provided.
 
Manufacturer Narrative
Product has been returned for evaluation however; evaluation has not been completed.
 
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Brand Name
UROLOGY INNER SHEATH
Type of Device
INNER RESECTOSCOPE SHEATH
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen, gm
Manufacturer (Section G)
KARL STORZ SE & CO.KG
dr.-karl-storz -strasse 34
78532
tuttlingen, gm
Manufacturer Contact
anja fair
2151 e. grand avenue
el segundo, CA 90245
4242188100
MDR Report Key14886306
MDR Text Key295699026
Report Number9610617-2021-00101
Device Sequence Number1
Product Code FBO
UDI-Device Identifier04048551077412
UDI-Public4048551077412
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27050CA
Device Catalogue Number27050CA
Device Lot NumberZP01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/06/2022
Initial Date FDA Received07/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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