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

Model Number 0010-2400

Device Problems Fracture (1260); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

It was reported that during a prostate procedure, forward firing was and blinking of the fiber occurred.The console prompted a courtesy message that the fiber was overheating.There was no tissue present on the scope or fiber to cause overheating.No prostrate/bladder stone were present for laser beam to come in contact to cause overheating.The case was completed utilizing a second fiber without clinical consequences to the patient.

Manufacturer Narrative

Analysis of the returned device revealed the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone of the bevel edge.The fiber proximal to fracture can rotate independently of outer flow tubing.The glass cap exhibits moderate devitrification at output window.The metal cap exhibits severe char on surface, and indications of slight melting on output window.The outer flow tubing open end exhibits minor scratch marks.Based on device analysis, the potential for forward firing may exist.The probable root cause was determined 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.An evaluation conclusion code of cause cannot be traced to device was assigned to this investigation.

Event Description

It was reported that during a prostate procedure, forward firing and blinking of the fiber occurred after 137,280j of fiber use.The console prompted a courtesy message that the fiber was overheating.There was no tissue present on the scope or fiber to cause overheating.No prostrate/bladder stone were present for laser beam to come in contact to cause overheating.The tip of the fiber was cleaned during procedure the case was completed utilizing a second fiber without clinical consequences to the patient.

• 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: 7862683
• MDR Text Key: 119791128
• Report Number: 2937094-2018-00993
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• 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,Followup
• Report Date: 08/30/2018

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: 04/19/2020
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 22012232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 09/03/2018
• Supplement Dates FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• 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