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); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that at (b)(6) joules of use and 15:27 minutes, while using the side-firing surgical fiber during a prostate procedure, the "aiming beam end-firing".The procedure was continued using a second surgical fiber.At (b)(6) joules while completing the case in coagulation mode for "minor bleeding" with the second fiber, the fiber tip reportedly detached inside of the patient and was retrieved.The procedure was completed using the second surgical fiber.Patient outcome: "ok" - there was no injury reported.This report is for the second surgical fiber used.

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 within the metal cap is detached and returned; the glass cap exhibits severe devitrification at the output window; the glass cap output area appears depressed; the metal cap exhibits mild detritus adhesion; the outer flow tubing open end appears stretched.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: 4776393
• MDR Text Key: 5949299
• Report Number: 2937094-2015-00473
• 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: 04/21/2015

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: 01/31/2017
• Device Model Number: 0010-2400
• Device Lot Number: 504A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2015
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1