MAUDE MDR 4795717

MDR report key: 4795717
Report number: 3002807715-2015-00020
Event key: 0
Event type: 3
Date of event: 2015-01-01
Date received: 2015-05-22
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 100
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: NEO YAMAGUCHI
Address: 47651 WESTINGHOUSE DR FREMONT CA 94539 US
Phone: 510-510-5103
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	YC-1800	ND: YAG LASER	NIDEK CO., LTD	LXS	YC-1800						Y	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2015-05-22	0

Event Narratives#

D

Patient 1

NIDEK INC RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2015. CUSTOMER REPORTED THAT DURING THE USE OF YC-1800 SN: (B)(4) LASER MADE A BEEPING SOUND AND THE RESIDENT DOCTOR NOTICED THAT THE DISPLAYED POWER HAD DOUBLED. DOCTOR DECREASED POWER TO WHAT IT WAS PREVIOUSLY SET AND CONTINUED TREATING THE PT. THE PROCEDURE WAS COMPLETED AND NO INJURY WAS REPORTED THAT TIME.

N

Patient 1

THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVAL. HOWEVER, A NIDEK FIELD SERVICE ENGINEER (FSE) HAD CONDUCTED AN ON-SITE EVAL. THE DEVICE WAS EVALUATED AND TESTED FOR PROPER FUNCTION. FSE CONFIRMED THAT THE DEVICE HAS BEEN FUNCTIONING WITHIN SPECS. NO PROBLEM WAS FOUND. FSE IDENTIFIED THAT THE DOCTOR WAS USING THE ENERGY CONTROL BUTTON TO INCREASE THE POWER WHEN HE WANTED TO INCREASE THE POWER IN SMALL AMOUNT. (ENERGY CONTROL: IS USED TO SET ENERGY OF THE YAG LASER IN THE RANGE FROM 0.3 TO 10.0MJ IN 0.1 MJ INCREMENTS.) (REFERENCE: OPHTHALMIC YAG LASER SYSTEM YC-1800; OPERATORS MANUAL; 3.SYSTEM DESCRIPTION, 13 ENERGY CONTROL) FSE EXPLAINED TO THE DOCTOR TO USE TO JOYSTICK TO INCREASE THE POWER IN MINOR AMOUNTS I.E. 0.2 MJ. NIDEK CONFIRMED THAT THERE WAS NO PT INJURY AND THE TREATMENT WAS COMPLETED. NIDEK INC CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04987669100073	OPHTHALMIC YAG LASER SYSTEM	NIDEK CO.,LTD.	LXS	2016-06-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K023045	LXS	MICRORUPTER V	Meridian AG	2002-09-26
510(k)	K901605	LXS	PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.	Phoenix Laser Systems, Inc.	1990-12-13
510(k)	K895864	LXS	MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP	Lasag AG	1989-12-29
510(k)	K893987	LXS	NIDEK MODEL YC-1200	Nidek, Inc.	1989-08-18
510(k)	K892204	LXS	NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS	Nidek, Inc.	1989-06-22
PMA	P830064S003	LXS	NEODYMIUM-YAG OP LASER OPL-3	Coburn Optical Ind., Inc.	1986-05-28
PMA	P840047	LXS	CILCO ND:YAG LASER	Coopervision-Cilco	1985-08-02
PMA	P830064S001	LXS	NEODYMIUM-YAG OP LASER OPL-3	Coburn Optical Ind., Inc.	1985-02-06
PMA	P830064S002	LXS	NEODYMIUM-YAG OP LASER OPL-3	Coburn Optical Ind., Inc.	1984-12-13

MAUDE MDR 4795717

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

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