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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY SPOON FORCEPS, 5 FR.
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KARL STORZ SE & CO. KG BIOPSY SPOON FORCEPS, 5 FR. Back to Search Results
Model Number 26159BHW
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 05/18/2026
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
Event or Problem Description
It was reported that while in the uterine cavity, the hinge screw of the biopsy forceps came loose.Could not find the screw (very minuscule).
 
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Brand Name
BIOPSY SPOON FORCEPS, 5 FR.
Common Device Name
BIOPSY SPOON FORCEPS, 5 FR.
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key25585507
Report Number2020550-2026-01422
Device Sequence Number20271794
Product Code GCJ
UDI-Device Identifier04048551094242
UDI-Public04048551094242
Combination Product (Y/N)N
Initial Reporter CountryNL
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/22/2026
Report Date (Section F) 06/22/2026
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 Number26159BHW
Device Catalogue Number26159BHW
Device Lot NumberWO01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/22/2026
Event Location Hospital
Date Report to Manufacturer06/22/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/22/2026
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 Other;
Patient SexUnknown
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