FDA.reportPublic FDA data

MAUDE MDR 5912720

MDR report key
5912720
Report number
1221826-2016-00129
Event key
0
Event type
3
Date of event
2016-07-12
Date received
2016-08-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. SUSIE CHEN
Address
2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US
Phone
424-424-4242
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLEXIBLE VIDEO CYSTOSCOPEFLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISIONFBO11272VNU11272VNUY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-2901. O

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.