GREENLIGHT MOXY FIBER OPTIC

MDR report key: 3841345 · Received May 30, 2014

Report

Report Number: 2937094-2014-00413
Event Type: Malfunction
Date Received: May 30, 2014
Date of Event: May 20, 2014
Report Date: May 20, 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

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (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 MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE CHAR. 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 WOULD LIMIT THE PERFORMANCE OF THE FIBER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE AIMING BEAM FIRES STRAIGHT OUT OF THE FIBER @ 141,352 JOULES (FORWARD FIRING). WHILE WORKING ON A MEDIUM SIZED GLAND., A LOT OF PROSTATIC STONES WERE UNCOVERED IN TISSUE. DOCTOR WORKED AROUND STONES FIBER WOULD FLASH. AFTER A FEW MOMENTS LASER ENERGY BEGAN TO FIRE STRAIGHT OUT OF TIP. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. PATIENT OUTCOME WAS REPORTED AS "OK."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
318813	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