MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-2400

Device Problems Bent (1059); Break (1069); Melted (1385); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the glass cap exhibits severe devitrification at output window; the metal cap exhibits moderate detritus adhesion on surface, and indications of slight melting on output window; the fiber is broken within the outer flow tubing at 2 inches from control knob, between distal tip and control knob, and exhibits indication of bending, crushed, and slight melting at break location; the fiber was tested with hene laser fixture, aim beam is present at break location; the outer flow tubing open end exhibits minor scratch marks, and mild contamination, likely biologic.Based on device analysis, the potential for forward firing may exist.Probable root cause: based on the device analysis, 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.

Event Description

It was reported that during a prostate procedure at 178,492 joules of use and 18 minutes, "fiber broke" was observed.It was further reported that there was a "breakage at insertion site of working element." the fiber tip (cap) was not cleaned during the procedure.The fiber was exchanged and the procedure was completed utilizing a second fiber.Patient's outcome "ok" reported.

• Brand Name: GREENLIGHT MOXY FIBER OPTIC
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• Manufacturer Contact: jennifer mascioli-tudor ; 3070 orchard drive; san jose, CA 95134 ; 4084563300
• MDR Report Key: 6081826
• MDR Text Key: 59354118
• Report Number: 2937094-2016-01079
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 0010-2400
• Device Lot Number: 622A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1