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

Model Number	0010-6122
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber (b)(4): the fiber distal end exhibits no sign of usage; the fiber is broken and detached 6.5 inches from connector; the white tubing is broken at.5 inches from the connector; the fiber exhibits signs of melting at both break locations; the white tubing is burnt at break location; the fiber was tested with hene laser fixture, aim beam is visible at white tubing break location.Probable root cause: based on the device analysis, the probable root cause of the failure is: user handling.
Event or Problem Description
It was reported that during stapedotomy procedure aim beam was tested and no aim beam present at the end of the fiber was observed.The fiber was exchanged and second fiber was used to complete the procedure.It was further reported that after the procedure the hospital technician tried the fiber once more and laser shot straight through the fiber.Patient outcome: no patient injury was reported.

• Brand Name: ENDOSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• MDR Report Key: 7009647
• Report Number: 2937094-2017-00971
• Device Sequence Number: 1184754
• Product Code: GEX
• UDI-Device Identifier: 00878953000053
• UDI-Public: 00878953000053
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2019
• Device Model Number: 0010-6122
• Device Catalogue Number: 0010-6122
• Device Lot Number: 647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1