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

Model Number	0010-6110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: failure analysis for fiber 0010-2090-721h-(b)(4): the fiber does not exhibit signs of usage; the fiber is broken within the white tubing at 8.25 inches from control knob, between the connector and control knob; the fiber was tested with hene laser fixture, aim beam is present at location of the break; the white tubing does not exhibit signs of melting at the break.Review of lot 721h dhr did not indicate any failures upon the final inspection.Probable root cause: based on the device analysis, the probable root cause of the failure could not be established based on the results of the investigation.
Event or Problem Description
It was reported that during a surgical procedure, the fiber did not work.The fiber was exchanged and the procedure was completed utilizing a second fiber.Patient outcome: no injury to the patient was reported.

• Brand Name: ACCUSTAT
• 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: 7482875
• Report Number: 2937094-2018-00451
• Device Sequence Number: 1543111
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2020
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1