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); Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Event Description

It was reported that during a benign prostatic hyperplasia (bph) procedure, after 11,071 joules and 0:23:51 minutes of use, fiber break - fiber stopped working were noted.The procedure was complete utilizing a second fiber (another of the same device).The patient's condition following procedure was reported as stable.No injury reported.

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 devitrification at the output area, and detritus adhesion around output area; the heat shrink tubing exhibits minor scratch marks; the control knob separated into two pieces; the knob portion is attached to the optical fiber; the snap cap portion is attached to white tubing jacket; 1.25 inches of optical fiber is exposed between the knob and snap cap.Probable root cause: based on the device analysis, the probable root cause of the failure is operational context based on 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.Fiber cap condition would result in reduced vaporization efficiency; based on the device analysis, the potential for forward firing may exist.

• 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: 7862681
• MDR Text Key: 119791179
• Report Number: 2937094-2018-00996
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953004709
• UDI-Public: 00878953004709
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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: 09/29/2018
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 640H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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