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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 06/22/2022
Event Type  malfunction  
Manufacturer Narrative
Product evaluation findings "ceramic tip broke off from the distal end and shaft is bent indicating force applied in evidence of use".We have been unable to obtain any information regarding the incident from the facility.
 
Event Description
The ceramic distal tip of the sheath broke off inside patient in one piece during a procedure.
 
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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,
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 Key15075501
MDR Text Key296594960
Report Number9610617-2022-00124
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number27050CA
Device Catalogue Number27050CA
Device Lot NumberWO02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2022
Initial Date FDA Received07/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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