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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION URETERO-RENO-FIBERSCOPE FLEX-X² FLEX-X² SCOPE

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KARL STORZ ENDOVISION URETERO-RENO-FIBERSCOPE FLEX-X² FLEX-X² SCOPE Back to Search Results
Model Number R11278AUK1
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2019
Event Type  malfunction  
Manufacturer Narrative
We evaluated the subject flexible scope and we found multiple cuts and tooling/grab marks throughout the length of the angle cover. The damage begins at the distal thread wrap area and continues back to the proximal thread wrap. It appears this is damage caused by instruments used during the procedure. The distal head weld had completely separated on one side and partially separated on the other. This type of damage would take excessive force. The flexible ureteroscope has been in use for approximately 5 months.
 
Event Description
During a ureteroscopy procedure the distal wrap of the scope came apart inside the patient's bladder. The broken piece was retrieved and the procedure was completed with no impact on the patient.
 
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Brand NameURETERO-RENO-FIBERSCOPE FLEX-X²
Type of DeviceFLEX-X² SCOPE
Manufacturer (Section D)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton MA 01507
Manufacturer (Section G)
KARL STORZ ENDOVISION
91 carpenter hill road
charlton MA 01507
Manufacturer Contact
susie chen
2151 east grand avenue
el segundo, CA 90245-5017
MDR Report Key8313098
MDR Text Key135424678
Report Number1221826-2019-00013
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982905
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 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberR11278AUK1
Device Catalogue NumberR11278AUK1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
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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