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 Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907); Temperature Problem (3022)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that during a prostate procedure, the fiber broke off in patient.Physician was able to remove broken fiber using graspers.No additional information provided.Patient outcome ¿no injury¿ reported.

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the fiber is broken within the heat shrink tubing and detached 2.5 cm form the distal end; there is signs of melting of the fiber at the break; the shrink tubing is fractured at the uv glue zone where the glass cap attaches to the fiber; the distal part of the fiber was returned in 3 pieces; the glass cap distal end, the glass cap main part and a piece of fiber; the glass cap distal end exhibits a drilled through condition; there is some white unknown substance noted inside the fiber cap; the bevel section is melted; the glass cap main part exhibits melting of the heat shrink tubing and blackening of the fiber within; the piece of fiber is 3mm long and appears blackened.Based on the analysis above, 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 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: 4704147
• MDR Text Key: 5716487
• Report Number: 2937094-2015-00376
• 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,Followup
• Report Date: 04/13/2015

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: 0010-2090
• Device Lot Number: 437H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2015
• 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