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 Fracture (1260); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: failure analysis for fiber 0010-2090-513h-(b)(4): the fiber cap exhibits signs of melting which formed a hole from the surface to the bevel edge; there are cracks at the fiber/glass cap fusion zone; the glass cap exhibits devitrification at the output area, and detritus adhesion around output area; the heat shrink tubing exhibits minor scratch marks; expiration date is 03/2017.Based on the 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: operational context.Additional information: the probable root cause was determined 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.

Event Description

It was reported that the first fiber was used for 56 minutes during a benign prostatic hyperplasia (bph) procedure.The reason the fiber was replaced was not provided.The tip of the fiber was not cleaned during the procedure.However, based on the lot number provided for the first fiber it appears that the fiber was used past the expiration date.

• 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: 7875778
• MDR Text Key: 120406675
• Report Number: 2937094-2018-01012
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 08/06/2018

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: 03/31/2017
• Device Model Number: 0010-2090
• Device Catalogue Number: 0010-2090
• Device Lot Number: 513H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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