FDA.reportPublic FDA data

MAUDE MDR 6499095

MDR report key
6499095
Report number
2027111-2017-01718
Event key
0
Event type
3
Date of event
2017-03-17
Date received
2017-04-17
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#

Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1B1005, ACUCISE ENDOPYELOTOMY SYSTEMEYB, DXT, KOG, EZB, KNYAPPLIED MEDICAL RESOURCESEYBB10051005405011269001Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-170

Event Narratives#

N

Patient 1

THIS MODEL HAS MULTIPLE PRODUCT CODES: EYB, DXT, KOG, EZB, KNY. THIS MODEL HAS MULTIPLE 510(K) CODES: K921838, K880987, K920030, K944135, K980987. THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

CYSTO RPG URETEROSCOPY AND POSSIBLE ENDOPYELOTOMY - THE BALLOON BURST DURING SURGERY. IT WAS NOT KNOWN HOW MANY TIMES AND HOW LONG THE CUTTING WIRE WAS ACTIVATED. THE COORDINATOR NOTED THE PRODUCT WAS RELATED TO A BK024 ACUCISE PACK. TYPE OF INTERVENTION: OPENED A 2ND KIT. PATIENT STATUS: NO PATIENT INJURY REPORTED.

N

Patient 1

THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING WAS ABLE TO CONFIRM THE COMPLAINANT'S EXPERIENCE OF A RUPTURED BALLOON. THERE WAS DAMAGE OBSERVED ON THE COATING ON THE CUTTING WIRE, WHICH WAS CHARRED. IT IS LIKELY THAT THE BALLOON RUPTURED DUE TO HIGH THERMAL ACTIVITY OF THE CUTTING WIRE. THE INSTRUCTIONS FOR USE (IFU) STATES, "GENERATOR SETTING SHOULD BE AT 75 WATTS, PURE CUT MODE. NEVER USE A COAGULATION SETTING... THE POWER SETTING MUST NEVER EXCEED 100 WATTS... AND ...DO NOT EXCEED 5 SECONDS CONTINUOUS CUTTING TIME. TISSUE CHARRING, BALLOON RUPTURE, AND/OR WIRE BREAKAGE CAN OCCUR IF 5 SECONDS IS EXCEEDED." APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.