FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 4003173 · Received August 12, 2014

Report

Report Number: 2937094-2014-00711
Event Type: Malfunction
Date Received: August 12, 2014
Date of Event: June 25, 2014
Report Date: June 25, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Product Code: GEX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS FOR FIBER MODEL #0010-2400, LOT #351A, SERIAL #(B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE CHAR; THE OUTER FLOW TUBING EXHIBITS MODERATE CONTAMINATION, LIKELY BIOLOGIC. BASED ON THE ANALYSIS, 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT AT 282,866 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER STOPPED FUNCTIONING / NO TISSUE VAPORIZATION WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. PATIENT OUTCOME: "GOOD" - THERE WAS NO INJURY REPORTED. GLAND VOLUME: 100+ ML. TIME EXPENDED: 41:37 MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
478782	GREENLIGHT MOXY FIBER OPTIC	POWERED LASER SURGICAL INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)	0010-2400	351A

Patients

Seq	Age	Sex	Outcome	Treatment
1