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

Model Number 0010-2090

Device Problems Charred (1086); Melted (1385); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

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

Event Date 08/20/2014

Event Type  malfunction  

Event Description

It was reported that during a bph prostate procedure, the customer reported; "no aiming beam/no tip" at 8,365 joules and 02:00 minutes of usage.The case was completed with a second fiber.Patient outcome: "no injury to patient" reported.

Manufacturer Narrative

Product evaluation: failure analysis for fiber 0010-2090-407h-(b)(4): the fiber cap exhibited a drilled through condition; the fiber tip is still intact and attached; there was some white unknown substance noted inside the fiber cap; the bevel section is melted; the glass cap exhibited severe detritus adhesion and severe devitrification; the glass fiber inside of fiber cap is blackened.Based on the analysis above, the potential for forward firing may also 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 limiting the performance of the fiber.(b)(4) refers to forward-firing of the side-firing surgical fiber; a code request has been submitted.

• Brand Name: GREENLIGHT HPS BPH 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: 4239256
• MDR Text Key: 5016278
• Report Number: 2937094-2014-01032
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: 0010-2090
• Device Lot Number: 407H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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