FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 3851923 · Received June 5, 2014

Report

Report Number: 2937094-2014-00446
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: March 31, 2014
Report Date: April 16, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Product Code: GEX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER/GLASS CAP EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/GLASS CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITED MODERATE BURNT ON DETRITUS; THE GLASS CAP EXHIBITED MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE OUTER FLOW TUBING EXHIBITED SIGNS OF CONTAMINATION, LIKELY BIOLOGIC. THE POTENTIAL FOR FORWARD FIRING MAY ALSO 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 LIMITING THE PERFORMANCE OF THE FIBER.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE USING THE FIBER DURING A PROSTATE PROCEDURE, THE FIBER WAS BLINKING AND CONSTANTLY TURNED OFF. THE SURGICAL FIBER WAS REPLACED AND THE PROCEDURE COMPLETED USING A SECOND FIBER. PATIENT OUTCOME: "NO DAMAGES TO THE PATIENT". THERE WAS NO INJURY REPORTED. GLAND VOLUME: 80 G TIME EXPENDED: 16 MINUTES JOULES USED: 82,052

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328532	GREENLIGHT MOXY FIBER OPTIC	POWERED LASER SURGICAL INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)	0010-2400	344A

Patients

Seq	Age	Sex	Outcome	Treatment
1