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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR RESECTOSCOPE
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KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR RESECTOSCOPE Back to Search Results
Catalog Number 27050
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/10/2020
Event Type  malfunction  
Event Description
Following dilatation of the penile urethra, a bipolar resectoscope was inserted via the urethra into the urinary bladder.Bladder lesion was resected in standard fashion while avoiding full-thickness bladder perforation or injury.Lesion was completely resected, and all chips were evacuated and sent to pathology for permanent section.Each area of lesion was resected separately.After resecting the left bladder neck and the prostatic urethra, the distal tip of the resectoscope broke off.The resectoscope was exchanged for a cystoscope; the broken tip was then able to be removed from the patient's urethra using an alligator grasper.No remaining fragments were seen in the bladder.
 
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Brand Name
BIPOLAR RESECTOSCOPE
Type of Device
RESECTOSCOPE
Manufacturer (Section D)
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand avenue
el segundo CA 90245
MDR Report Key10553223
MDR Text Key207519206
Report Number10553223
Device Sequence Number1
Product Code FJL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number27050
Device Lot NumberTQ06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2020
Event Location Hospital
Date Report to Manufacturer09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24090 DA
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