FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 4192926 · Received October 22, 2014

Report

Report Number: 2937094-2014-00967
Event Type: Malfunction
Date Received: October 22, 2014
Date of Event: September 5, 2014
Report Date: September 11, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Product Code: GEX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER/GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE DISTAL GLASS TIP OF THE FIBER WAS NOT RETURNED; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS MODERATE CHAR; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH WOULD LIMIT THE PERFORMANCE OF THE FIBER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FIBER OVERHEATED @ APPROXIMATELY 24 MINUTES OF USE. 220,000 JOULES OF USE. A SECOND FIBER WAS OPENED WHICH ALSO OVERHEATED AFTER APPROXIMATELY 6 MINUTES OF USE BUT CUSTOMER WAS ABLE TO CONTINUE THE SURGERY AND COMPLETE THE PROCEDURE. THERE WAS ¿NO INJURY TO THE PATIENT¿ REPORTED. THIS EVENT IS FOR THE SECOND FIBER USED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
673611	GREENLIGHT MOXY FIBER OPTIC	POWERED LASER SURGICAL INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)	0010-2400	407A

Patients

Seq	Age	Sex	Outcome	Treatment
1