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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL
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KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL Back to Search Results
Model Number 27050XA
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Discomfort (2330); Foreign Body In Patient (2687)
Date of Event 07/01/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a piece of a ceramic beak was found and removed from patient's bladder in (b)(6) 2024.It has been advised that the initial procedure was in 2019.Patient had experienced infections and pain post op 2019.
 
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal (b)(6) complaint id: (b)(4).
 
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Brand Name
INNER SHEATH FOR 27050 SL
Common Device Name
INNER SHEATH
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key20800940
Report Number2020550-2024-00480
Device Sequence Number7883164
Product Code HIH
UDI-Device Identifier04048551078136
UDI-Public04048551078136
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/27/2024
Report Date (Section F) 11/27/2024
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
Operator of Device Health Professional
Device Model Number27050XA
Device Catalogue Number27050XA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/26/2024
Event Location Hospital
Date Report to Manufacturer11/27/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/27/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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