MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) SUREFLEX FIBERS; POWERED LASER SURGICAL INSTRUMENT

Model Number S-LLF910

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the total length of the fiber was 12 feet 1 inch; the glass fiber exhibited signs of devitrification; the distal end of the glass fiber was fractured and extended 0.5mm from the blue outer sheath; the distal end of the blue outer sheath appeared in good condition; the fiber was tested with hene laser fixture, aim beam was visible at the tip and the light spot created by the aim beam appeared not acceptable.Probable root cause: based on the product analysis results, the probable root cause of the failure is: undetermined.

Event Description

It was reported that while using two fibers to break up a stone during a lithotripsy procedure, the fiber tips broke off inside the patients bladder, resulting in a delay of case with increased anesthesia time.The patient's bladder was evacuated and the fiber tips were recovered.There was no patient injury reported.This report is for the second fiber used.

• Brand Name: SUREFLEX FIBERS
• 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: 4508427
• MDR Text Key: 14147246
• Report Number: 2937094-2015-00128
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

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: 08/31/2017
• Device Model Number: S-LLF910
• Device Lot Number: 433A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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