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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. FLEX-X² FLEXIBLE URETEROSCOPE, 7.5FR

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KARL STORZ ENDOVISION, INC. FLEX-X² FLEXIBLE URETEROSCOPE, 7.5FR Back to Search Results
Model Number R11278AUK1
Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problems Perforation (2001); Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
The customer has not responded to our attempts to gather further information, and per our understanding, they will not be returning product r11278auk1.
 
Event Description
Per medwatch report, ## (b)(4), received on 11/25/19, it was reported the patient was undergoing a cystoscopy, right retrograde pyelogram, and ureteroscopy with laser lithotripsy. Per the operative report, a complication was encountered when the ureteroscope became stuck in the mid ureter upon withdrawal. The provider had difficulty withdrawing or advancing. The scope was successfully withdrawn after very gentle rotation of the scope and sheath. The ureter suffered a perforation. The md noted "it appeared that the sheathing came off the ureteroscope causing the perforation. " a stent was placed to treat the perforation and the patient was admitted for observation.
 
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Brand NameFLEX-X² FLEXIBLE URETEROSCOPE, 7.5FR
Type of DeviceFLEX-X²
Manufacturer (Section D)
KARL STORZ ENDOVISION, INC.
91 carpenter hill road
charlton MA 01507
Manufacturer (Section G)
KARL STORZ ENDOVISION, INC.
91 carpenter hill road
charlton MA 01507
Manufacturer Contact
susie chen
2151 east grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key9438256
MDR Text Key169880144
Report Number1221826-2019-00115
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K925128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberR11278AUK1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/09/2019 Patient Sequence Number: 1
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