FLEXIBLE VIDEO CYSTOSCOPE 11272VNU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-29 for FLEXIBLE VIDEO CYSTOSCOPE 11272VNU manufactured by Karl Storz Endovision.

Event Text Entries

[53446153] The product evaluation concluded the following: shaft has over bends next to strain relief. Monocoil to vertebrae welding break. Multiple scrape marks inside channel with bump, no leak found. Voids around spread lens and ccd window with debris. Chipped spread lens. Debris at handle housing and at hand grip surface. Kinked umbilical cord. Broken light fibers inside handle housing and at vertebrae system. Debris at angle cover surface. The evidence produced from this investigation suggests that user error can be linked to the physical state of the instrument. The documented scope damage could be a contributory factor towards patient infection. In order to perform a microbiological assessment of the video cysto urethroscope (11272vnu, s/n (b)(4)), it was sampled by flushing all channels and the outer surfaces with process water. The samples were submitted to nelson laboratories to specifically determine if p. Aeruginosa was present. The final report from nelson laboratories confirmed that the organism in question (p. Aeruginosa) was not present in the samples analyzed.
Patient Sequence No: 1, Text Type: N, H10


[53446154] Allegedly, doctor performed a bladder tumor surgery and a diagnostic bladder cancer procedure. Post procedure, the patient exhibited symptoms. A urine culture was taken and it confirmed pseudomonas aeruginosa infection. The patient was prescribed mitomycin and is responding well to the treatment. There were 3 patients infected; this report is for patient #3.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221826-2016-00129
MDR Report Key5912720
Report SourceUSER FACILITY
Date Received2016-08-29
Date of Report2016-07-29
Date of Event2016-07-12
Date Mfgr Received2016-07-29
Device Manufacturer Date2016-12-20
Date Added to Maude2016-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. SUSIE CHEN
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 902455017
Manufacturer CountryUS
Manufacturer Postal902455017
Manufacturer Phone4242188201
Manufacturer G1KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
Manufacturer StreetMITTLESTRASSE 8, 78503
Manufacturer CityTUTTLINGEN, GERMANY,
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIBLE VIDEO CYSTOSCOPE
Generic NameFLEXIBLE VIDEO CYSTOSCOPE
Product CodeFBO
Date Received2016-08-29
Returned To Mfg2016-08-11
Model Number11272VNU
Catalog Number11272VNU
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ ENDOVISION
Manufacturer Address91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-29

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