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 Perforation (2205); Temperature Problem (3022)

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

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the fiber cap exhibits cratering and drilled through condition; the glass cap exhibits 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 at 3,693 joules and 25 minutes "fiber damaged at tip" and "didn't fire to the correct direction" were noted.The fiber was exchanged and the second fiber was used to complete the procedure at 298,570 joules.The tip of the fiber was cleaned during the procedure.No injury to the patient was 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: 6848816
• MDR Text Key: 85138850
• Report Number: 2937094-2017-00781
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 0010-2093
• Device Catalogue Number: 0010-2093
• Device Lot Number: 542J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• 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