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

Model Number 0010-2400

Device Problems Break (1069); Fracture (1260); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

It was reported that during a benign prostatic hyperplasia surgical procedure at 166,367 joules and 23:47 minutes of use; fiber tip damage and break were observed.The fiber tip was not cleaned during the procedure.The procedure was completed using second fiber at 185,708 joules and 28:06 minutes of use.Patient was reported to be "ok", no injury to patient was reported.

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge; the fiber proximal to fracture can rotate independently of outer flow tubing; the fiber is broken within the outer flow tubing at open end; the fiber was tested with hene laser fixture, aim beam was visible at fiber break; the glass cap exhibits severe devitrification at output window; the metal cap exhibits severe charred detritus adhesion on surface; the outer flow tubing open end exhibits minor scratch marks and tear.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: operational context based on 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.The identified issues noted above may activate the fiberlife function which would modulate the power showing a pulsing beam or system would be placed into standby mode.

• 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: alyson harris ; 3070 orchard drive; san jose, CA 95134 ; 4084563300
• MDR Report Key: 7876506
• MDR Text Key: 120406712
• Report Number: 2937094-2018-01015
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 743B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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
• Patient Age: 66 YR