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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS UROLOGY INNER SHEATH MODEL A22041A; RESECTOSCOPE
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OLYMPUS WINTER & IBE GMBH OLYMPUS UROLOGY INNER SHEATH MODEL A22041A; RESECTOSCOPE Back to Search Results
Model Number A22041A
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/25/2020
Event Type  Injury  
Event Description
Olympus urology inner sheath model a22041a insulated tip (entire tip) remained in patient's bladder after sheath was withdrawn.(surgeon was able to retrieve the tip.) after patient incident, tactile (in addition to routine visual) inspection of olympus urology inner sheath model a22041a tips instituted in sterile processing.During sheath inspection, entire tip came off of another sheath (same model).Another olympus urology inner sheath model a22041a was involved in another patient incident: portion of tip remained in patient's bladder as sheath was withdrawn at end of procedure.(surgeon was able to retrieve tip fragment.) fda safety report id # (b)(4).
 
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Brand Name
OLYMPUS UROLOGY INNER SHEATH MODEL A22041A
Type of Device
RESECTOSCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
MDR Report Key11036402
MDR Text Key222636263
Report NumberMW5098426
Device Sequence Number2
Product Code FJL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/16/2020
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberA22041A
Device Catalogue NumberA22041A
Device Lot NumberNONE AVAILABLE FOR THIS DEVICE
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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