FDA.reportPublic FDA data

MAUDE MDR 7251890

MDR report key
7251890
Report number
2951238-2018-00087
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, LOOP, 26 FRHF-RESECTION ELECTRODEOLYMPUS WINTER & IBE GMBHGCPA22202CA22202CP1710002R N

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. THE SECOND ELECTRODE (A22202C, LOT P1710002) WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, BASED ON THE SIMILAR REPORTED EVENTS RELATED TO THE DEVICE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT CAN OCCUR WHEN MECHANICAL OVERLOAD BY THE APPLICATION OF EXCESSIVE FORCE AND IMPROPER HANDLING, THE ELECTRODE COMES 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 WHICH COULD CAUSE THE LOOP WIRE OF 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. TWO OF SIX.