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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG INNER TUBE WITH CERAMIC BEAK; CYSTOURETHROSCOPE
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KARL STORZ GMBH CO. KG INNER TUBE WITH CERAMIC BEAK; CYSTOURETHROSCOPE Back to Search Results
Model Number 27050XA
Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)
Patient Problem No Information (3190)
Event Date 04/10/2018
Event Type  malfunction  
Event Description
Patient was in the operating room (or) for a cystoscopy and transurethral resection of the prostate (turp).Inner sheath of karl storz instrument had the tip covered in plastic.Plastic cracked and pieces of plastic broke off into the patient bladder.Dr.Irrigated and used graspers to retrieve the pieces of plastic.He irrigated the bladder copiously and inspected the bladder thoroughly under video endoscopy to ensure no pieces were left in the bladder.
 
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Brand Name
INNER TUBE WITH CERAMIC BEAK
Type of Device
CYSTOURETHROSCOPE
Manufacturer (Section D)
KARL STORZ GMBH CO. KG
2151 e grand ave.
el segundo CA 90245 5017
MDR Report Key7428297
MDR Text Key105395480
Report Number7428297
Device Sequence Number1
Product Code FBO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number27050XA
Device Catalogue Number27050XA
Device Lot NumberSW06
Other Device ID Number26 FR INNER CONTINUOUS IRRIGA
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2018
Event Location Hospital
Date Report to Manufacturer04/12/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age66 YR
Patient Weight109
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