FDA.reportPublic FDA data

MAUDE MDR 9849865

MDR report key
9849865
Report number
2951238-2020-00382
Event key
0
Event type
3
Date of event
2019-03-13
Date received
2020-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INNER SHEATH, FOR 26 FR. OUTER SHEATHRESECTOSCOPE SHEATHOLYMPUS WINTER & IBE GMBHHIHA22040AA22040A131W-0213R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1801. R

Event Narratives#

D

Patient 1

THE SERVICE CENTER RECEIVED A MEDWATCH REPORT, MW5092847, ON FEBRUARY 26, 2020 FOR ONE BIPOLAR RESECTOSCOPE SHEATH WHICH TIP BROKE DURING A PROCEDURE. THE REPORT WAS FOR MODEL A22040A, RIGID CYSTOSCOPE SHEATH, LOT NUMBER 131W-0213, THAT WAS USED BY A PHYSICIAN DURING A RIGID CYSTOSCOPY. IT WAS REPORTED THE UROLOGIST OBSERVED A GRAY/SILVER- COLORED, HALF-CIRCLE SHAPED ITEM PRESENT IN THE BLADDER DURING THE PROCEDURE. UPON INSPECTION OF THE DEVICE, UROLOGY NOTED THE TIP OF THE BIPOLAR CYSTOSCOPE SHEATH WAS BROKEN AND MISSING. THE PHYSICIAN OBTAINED AN X-RAY, AND THE PATIENT WAS TRANSFERRED TO A TERTIARY SITE FOR REMOVAL OF THE BROKEN PIECE AND MANAGEMENT OF THE CONDITION. THE MEDWATCH REPORT INDICATED THAT THIS WAS A SERIOUS INJURY AND NO FURTHER INFORMATION WAS PROVIDED.