FDA.reportPublic FDA data

MAUDE MDR 8293453

MDR report key
8293453
Report number
2951238-2019-00393
Event key
0
Event type
3
Date of event
2018-12-31
Date received
2019-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1VISERA CYSTO-NEPHRO VIDEOSCOPECYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWBCYF-V2Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-310

Event Narratives#

N

Patient 1

THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION OF THE REFERENCED SCOPE FOUND THE BENDING SECTION COVER GLUE WAS CRACKED EXPOSING THE THREADING AT THE BENDING SECTION WHICH WOULD INDICATE THAT A PIECE OF THE BENDING SECTION COVER GLUE WAS MISSING. THE BENDING SECTION COVER, DISTAL END PLASTIC COVER AND INSERTION TUBE WERE INTACT. THE SCOPE DID NOT PASS THE LEAK TEST DUE TO THE CRACKED BENDING SECTION COVER GLUE AT THE DISTAL END. THERE WERE 385 USAGES WITH THE DEVICE. A REVIEW OF THE SCOPE?S INSTRUMENT HISTORY RECORD SHOWS THE SCOPE WAS PURCHASED IN (B)(4) 2013 AND WAS LAST REPAIRED ON APRIL 20, 2017. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED, HOWEVER, THE IFU?S TROUBLESHOOT SECTION WARNS, ?IF ANY PARTS OF THE ENDOSCOPE FALL OFF INSIDE THE PATIENT?S BODY DUE TO EQUIPMENT DAMAGE OR FAILURE, STOP USING THE ENDOSCOPE IMMEDIATELY AND RETRIEVE THE PARTS IN AN APPROPRIATE WAY.? THE INSTRUCTION MANUAL ALSO PROVIDES WARNING AND CAUTIONS WHICH STATE? DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE?S DISTAL END, INSERTION TUBE, BENDING SECTION, AND CONTROL SECTION WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, SUCH AS BURNS, BLEEDING, AND/OR PERFORATION. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT.?

D

Patient 1

OLYMPUS WAS INFORMED THAT AFTER PERFORMING A CYSTOSCOPY PROCEDURE, THE DOCTOR SAW A SMALL BLACK FRAGMENT INSIDE THE PATIENT?S BLADDER. THE SCOPE WAS THEN INSPECTED AND THE DOCTOR NOTICED A PIECE OF THE DISTAL END COVER WAS MISSING. THE SMALL BLACK FRAGMENT IN PATIENT'S BLADDER COULD NOT BE RETRIEVED BY THE STAFF AS THEY ATTEMPTED SEVERAL TIMES. THE USER FACILITY REPORTED THAT "BECAUSE IT IS SMALL IN SIZE THE PATIENT WILL EVENTUALLY URINATE IT OUT. THE PROCEDURE WAS COMPLETED AS THE BLACK PIECE WAS ONLY NOTED AT THE END OF THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. IN ADDITION, THE PATIENT DID NOT REQUIRE A LONGER STAY OR ADDITIONAL TREATMENT. THE SCOPE WAS INSPECTED WITH NO ANOMALIES OBSERVED.