FDA Adverse Event Malfunction Summary report: N

GREENLIGHT MOXY FIBER OPTIC

MDR report key: 4180010 · Received October 17, 2014

Report

Report Number: 2937094-2014-00947
Event Type: Malfunction
Date Received: October 17, 2014
Date of Event: September 17, 2014
Report Date: September 26, 2014
Manufacturer: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
Product Code: GEX
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PR, 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 METAL CAP IS MELTED AT THE OUTPUT WINDOW LOCATION; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW. BASED ON THE DEVICE 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.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER 21 MINUTES WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE OUTPUT BEAM WAS OBSERVED TO BE FORWARD-FIRING. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. PATIENT OUTCOME: "OK" - THERE WAS NO INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
662782	GREENLIGHT MOXY FIBER OPTIC	POWERED LASER SURGICAL INSTRUMENT	GEX	AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)	0010-2400	419A

Patients

Seq	Age	Sex	Outcome	Treatment
1