FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 3874298 · Received June 16, 2014

Report

Report Number: 2937094-2014-00508
Event Type: Malfunction
Date Received: June 16, 2014
Date of Event: June 4, 2014
Report Date: June 4, 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 EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITED SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITED MODERATE BURNT ON DETRITUS. 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 LIMITING THE PERFORMANCE OF THE FIBER.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE FIBER WAS OBSERVED TO FIRE STRAIGHT OUT OF THE FIBER @ 277,147 JOULES (FORWARD FIRING). THE PROCEDURE WAS COMPLETED USING A SECOND FIBER @ 36,012 JOULES. THERE WAS ¿NO PATIENT INJURY¿ REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352181	GREENLIGHT MOXY FIBER OPTIC	POWERED LASER SURGICAL INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)	0010-2400	402A

Patients

Seq	Age	Sex	Outcome	Treatment
1