FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 3852006 · Received June 5, 2014

Report

Report Number: 2937094-2014-00447
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: March 12, 2014
Report Date: April 9, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Product Code: GEX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER/GLASS CAP EXHIBITED A RADIAL 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 MILD BURNT ON DETRITUS; THE GLASS CAP EXHIBITED MILD DEVITRIFICATION AT THE OUTPUT WINDOW; THE OUTER FLOW TUBING EXHIBITED SCRATCH MARKS AT THE OPEN END. BASED ON THE ANALYSIS, 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 AFTER CONNECTING THE SURGICAL FIBER FOR USE DURING A PROSTATE PROCEDURE, THE FIBER WOULD NOT FIRE. THE FIBER WAS REPLACED AND THE PROCEDURE COMPLETED USING A SECOND SURGICAL FIBER. PATIENT OUTCOME: "OKAY" - THERE WAS NOT INJURY REPORTED. GLAND VOLUME: 116 ML. TIME EXPENDED: 28:21 MINUTES. JOULES USED: 237,499.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328644	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