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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH ONLY
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KARL STORZ SE & CO. KG INNER SHEATH ONLY Back to Search Results
Model Number 27050CA
Device Problem Material Integrity Problem (2978)
Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
Item was found the beak was broken and missing the stopcock manifold.This type of occurrence most likely is related to mechanical force.
 
Event Description
Allegedly, the ceramic distal tip of the inner sheath broke off into the patient's bladder and was successfully retrieved.
 
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Brand Name
INNER SHEATH ONLY
Type of Device
INNER 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
susie chen
2151 east grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key11021695
MDR Text Key229594127
Report Number9610617-2020-00145
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 company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2020
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? Yes
Device Operator No Information
Device Model Number27050CA
Device Lot NumberUQ07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
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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