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); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that at 145,000 joules while using the surgical fiber during a prostate procedure, the fiber was observed to be "in firing".Time expended: 25 minutes.The fiber was replaced and the procedure completed using a second surgical fiber.There was no patient injury reported.

Manufacturer Narrative

Failure analysis for fiber (b)(4): the fiber/glass cap shows a circumferential fracture at distal side of fiber/cap fusion zone at the bevel edge; the distal end of the fiber/glass cap is detached and not returned; the fiber proximal to fracture at the bevel edge can rotate independently of metal cap; the glass cap at the output window exhibits severe devitrification at the output window; the metal cap exhibits moderate charred detritus adhesion.Based on the 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.

• 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: 4736969
• MDR Text Key: 5827287
• Report Number: 2937094-2015-00425
• 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: 02/17/2015

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: 09/30/2016
• Device Model Number: 0010-2400
• Device Lot Number: 439A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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