FDA.reportPublic FDA data

MAUDE MDR 7937063

MDR report key
7937063
Report number
2951238-2018-00607
Event key
0
Event type
3
Date received
2018-10-04
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
MS. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CYSTO-NEPHRO VIDEOSCOPECYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWBCYF-VHRCYF-VHRN R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-040

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND THE BENDING SECTION COVER GLUE FROM THE DISTAL END AND INSERTION TUBE SIDE CRACKED WITH PORTIONS OF THE CEMENT MISSING/BROKEN OFF. THE MISSING/BROKEN OFF CEMENT WAS NOT RETURNED. THERE WERE SCRATCHES NOTED ON THE BENDING SECTION COVER GLUE, WHICH LIKELY CAUSE THE DAMAGE TO THE CEMENT. THE SCOPE?S BIOPSY CHANNEL WAS INSPECTED WITH OLYMPUS TELESCOPE AND NO MISSING PARTS OR FOREIGN OBJECTS/MATERIALS WERE NOTED INSIDE THE CHANNEL. BASED ON THE REPORTED COMPLAINT THE CAUSE OF THE DAMAGE ON THE BENDING SECTION COVER CEMENT IS DUE TO MISHANDLING THE INSTRUCTION MANUAL PROVIDES WARNING WHICH STATES, ?DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE?S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE?S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, VIDEO CONNECTOR, OR LIGHT GUIDE CONNECTOR WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT.?

D

Patient 1

OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A PIECE OF THE SCOPE?S DISTAL TIP FELL INSIDE THE PATIENT'S BLADDER. IT IS UNKNOWN IF THE DEVICE FRAGMENT WAS RETRIEVED OR IF THE INTENDED PROCEDURE WAS COMPLETED.