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 Material Perforation (2205); Temperature Problem (3022)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the fiber cap exhibits signs of melting which formed a hole from the surface to the bevel edge; the glass cap exhibits severe devitrification at the output area, and detritus adhesion around output area; the heat shrink tubing exhibits minor scratch marks.Based on device analysis, the potential for forward firing may exist.Probable root cause: based on the device analysis, 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.

Event Description

It was reported that during a bph surgical procedure "premature failure" was noted.The fiber was exchanged and two additional "premature failures" were reported.A fourth fiber was used to complete the procedure.Patient outcome: "no injury" reported.This report is for the second 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: 7009536
• MDR Text Key: 92315621
• Report Number: 2937094-2017-00966
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: 00878953004709
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2018
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 648H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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