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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SEMI-RIGID 6º URETEROSCOPE W/STRAIGHT SEMI-RIGID SCOPE

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KARL STORZ SE & CO. KG SEMI-RIGID 6º URETEROSCOPE W/STRAIGHT SEMI-RIGID SCOPE Back to Search Results
Model Number 27011L
Device Problem Material Frayed (1262)
Patient Problems Excessive Tear Production (2235); Patient Problem/Medical Problem (2688)
Event Date 01/17/2019
Event Type  malfunction  
Manufacturer Narrative
We evaluated the subject semi-rigid ureteroscope and we found the distal end is a little rough from long uses. Scopes shaft is bent and with approximately 60% broken light fibers. The seni-rigid ureteroscope was in use for approximately 12 years, purchased (b)(6) 2007.
 
Event Description
Ureteroscope was placed into ureter and advanced toward the kidney. During removal, the ureter stuck to scope and was avulsed. The ureter could not be repaired and a nephrectomy was performed.
 
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Brand NameSEMI-RIGID 6º URETEROSCOPE W/STRAIGHT
Type of DeviceSEMI-RIGID SCOPE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM
Manufacturer Contact
susie chen
2151 east grand avenue
el segundo, CA 90245-5017
MDR Report Key8379098
MDR Text Key138408957
Report Number9610617-2019-00021
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K940464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27011L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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