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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ OBTURATOR SHEATH; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID

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KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ OBTURATOR SHEATH; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID Back to Search Results
Lot Number 0123 LOT CI
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
On (b)(6) 2019 pt had a transurethral resection of bladder greater than 3 cm.During the week of (b)(6) pt had an in-office scope where physician noticed small particles in bladder.This was believed to be parts of the plastic end of an obturator sheath.On (b)(6) 2020 physician performed a cystoscopy with fulguration and biopsy of bladder tumor and removal of foreign body.Pieces were retrieved.Sheath from central sterile had been found with broken end and removed from service.Rep of company notified.Physician said pt had experienced no issues due to the foreign body and would have had the procedure regardless.Fda safety report id# (b)(4).
 
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Brand Name
KARL STORZ OBTURATOR SHEATH
Type of Device
CYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
MDR Report Key9865104
MDR Text Key184665423
Report NumberMW5093865
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0123 LOT CI
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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;
Patient Age66 YR
Patient Weight98
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