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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO URETEROSCOPE, 8.5 FR. X 700MM

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KARL STORZ ENDOVISION VIDEO URETEROSCOPE, 8.5 FR. X 700MM Back to Search Results
Model Number 11278VSEK
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2023
Event Type  malfunction  
Event Description
It was reported that, during a urethroscopy/cystoscopy and intracorporeal laser lithotripsy on (b)(6) 2023 (on a 10 year old canine, male castrated, mastiff, about 155 lbs), the scope stopped working during the fragmentation of the second urolith, and thus a urethrotomy was needed to remove the residual stone.A back-up flex-x2s scope was used for retrieval of a stone fragment since the surgeon was not able to scope the dog after needing to abort lithotripsy to confirm that all fragments were removed.The canine had to recover in the icu due to surgery ending after hours.He was transferred to fluids wards the following morning where he remained hospitalized for four more days than anticipated to ensure proper healing of the urethra and prevent urethral strictures resulting from the surgical conversion.The total delay to the procedure was about 4 hours.
 
Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case (b)(4).
 
Manufacturer Narrative
Per evaluation findings by the manufacturer: no image.No light output.Puncture in the channel with a leak.Leaking at the seam of the ccu cable.Fluid invasion in the housing.This complaint was escalated due to a reported malfunction while in use resulting in a prolonged procedure.Product evaluation confirmed the image and light output failure noted in the complaint.Additional investigation has determined that this failure was attributed to fluid invasion which caused damage to the electronic components.Fluid ingress was caused by a defect in the housing material.
 
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Brand Name
VIDEO URETEROSCOPE, 8.5 FR. X 700MM
Type of Device
VIDEO URETEROSCOPE
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
anja fair
2151 e grand ave
el segundo, CA 90245
4242188247
MDR Report Key17326392
MDR Text Key319204291
Report Number1221826-2023-00161
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04048551417089
UDI-Public4048551417089
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 10/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number11278VSEK
Device Catalogue Number11278VSEK
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 06/15/2023
Initial Date FDA Received07/14/2023
Supplement Dates Manufacturer Received10/13/2023
Supplement Dates FDA Received10/18/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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