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); Appropriate Term/Code Not Available (3191)

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

Event Date 02/19/2018

Event Type  malfunction  

Event Description

It was reported that during a benign prostatic hyperplasia (bph) procedure, the laser irradiated forward.The procedure was completed with an alternative procedure (turp).There was no patient injury reported due to the event.

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the fiber cap exhibits drilled through condition; there is some white unknown substance noted inside the distal end of fiber cap; the glass cap exhibits devitrification at the output area, and detritus adhesion around output area; the heat shrink tubing exhibits minor scratch marks; the fiber was tested with hene laser fixture, the aim beam is present at the fiber tip; there are no signs of breakage along length of fiber.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 further reported that the fiber failed after 13,000 joules and 3 minutes of use.The fiber tip (cap) was cleaned during the procedure.

• 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: alyson harris ; 3070 orchard drive; san jose, CA 95134 ; 4084563300
• MDR Report Key: 7335870
• MDR Text Key: 102341893
• Report Number: 2937094-2018-00271
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: 00878953004709
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2019
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 725H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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