FDA.reportPublic FDA data

MAUDE MDR 7251920

MDR report key
7251920
Report number
2951238-2018-00088
Event key
0
Event type
3
Date of event
2018-01-12
Date received
2018-02-08
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
1HF-RESECTION ELECTRODE, ROLLER, 24-28 FRHF ELECTRODEOLYMPUS WINTER & IBE GMBHGCPA22251CA22251CP1780004Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-080

Event Narratives#

N

Patient 1

THE CUSTOMER RETURNED FIVE OF SIX ELECTRODES TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION OF THE THIRD ELECTRODE (A22251C LOT# P1780004) FOUND THE WIRE THAT HOLDS THE ROLLER BALL AT THE DISTAL TIP IS BROKEN AND SEPARATED FROM ONE OF THE SILVER COLORED RESECTION POSTS. THE ROLLER BALL IS INTACT. A MICROSCOPE INSPECTION OF THE BREAKAGE POINT FOUND THE ROLLER BALL AND THE RESECTION POST ARE DISCOLORED. THE INSULATION AT THE DISTAL TIP ON BOTH RESECTION POSTS ARE CHARRED, BURNED AND MELTED. NO PART OF WIRE THAT HOLDS THE ROLLER IN PLACE IS SUSPECTED TO BE MISSING. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AS THE USER FACILITY DID NOT RETURN THE CONCOMITANT DEVICES FOR TESTING. HOWEVER, BASED ON SIMILAR REPORTED EVENTS THE MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD BE ATTRIBUTED TO THE ELECTRODE COMING INTO CONTACT (UNINTENDED) WITH OTHER METAL PARTS, E.G. SURGICAL INSTRUMENTS WHILE THE HIGH-FREQUENCY OUTPUT WAS ACTIVATED AND HIGHER OUTPUT SETTINGS ON THE ELECTROSURGICAL GENERATOR COULD CAUSE THE ELECTRODE TO BECOME DAMAGED.

D

Patient 1

OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE, THE LOOP WIRE ON TWO (A22202C) ELECTRODES AND THE ROLLER OF FOUR (A22251C) ELECTRODES BROKE OFF INSIDE OF A PATIENT. THE DEVICE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED ELECTRODE. NO PATIENT INJURY WAS REPORTED. FOUR OF SIX.