MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) AMS GREENLIGHT HPS FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-2093

Device Problems Material Fragmentation (1261); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the fiber/glass cap is partially fractured distal to the uv glue zone; the glass cap distal part is detached and not returned; the heat shrink tubing open end exhibits partially erased red octagonal sign and blue arrow indicator.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: 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 at 12 minutes and 63,358 joules of use while using the side-firing surgical fiber during a prostate procedure, the fiber output beam was observed to be forward-firing.The fiber tip (cap) was cleaned during the procedure.The fiber was replaced and the procedure completed using a second surgical fiber for 99,414 joules.There was no patient injury reported.

• Brand Name: AMS GREENLIGHT HPS FIBER
• 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: 6811445
• MDR Text Key: 83318131
• Report Number: 2937094-2017-00750
• Device Sequence Number: 1
• Product Code: GEX
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2017

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: 01/31/2018
• Device Model Number: 0010-2093
• Device Catalogue Number: 0010-2093
• Device Lot Number: 605J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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