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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL FLEX-X2S

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KARL STORZ ENDOVISION, INC. 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL FLEX-X2S Back to Search Results
Model Number R11278AUK1
Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536); Material Twisted/Bent (2981)
Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 02/01/2020
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 via us mail, the patient was undergoing bilateral ureteroscopies due to ureteral stones. Flexible ureteroscope placed into the left ureter. Laser was used to bust up the stones. As procedure continued, physician tried to pull the scope back. He met resistance and felt the scope was stuck. Retraction techniques utilized/attempted. Rigid cystoscope utilized. Upon, inspection, the outside lining of the flexible scope was very loose and was bunching.
 
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Brand Name7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL
Type of DeviceFLEX-X2S
Manufacturer (Section D)
KARL STORZ ENDOVISION, INC.
91 carpenter hill road
charlton, ma
Manufacturer (Section G)
KARL STORZ ENDOVISION, INC.
91 carpenter hill road
charlton, ma
Manufacturer Contact
susie chen
2151 east grand avenue
el segundo, ca 
2188201
MDR Report Key10027040
MDR Text Key189970528
Report Number1221826-2020-00057
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K925128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2018
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: 05/05/2020 Patient Sequence Number: 1
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