MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC ACCUSTAT; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-6110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications prior to release.Analysis of the device found that the fiber tip is fractured within the clear tubing at the tip end of the fiber.The clear tubing exhibits signs of crushing and stretching at the point of the fracture.The fiber was tested with hene laser fixture, aim beam is visible at the fiber break.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
Analysis of the device found that the fiber was fractured within the clear tubing at the tip end of the fiber.Patient outcome information was not provided.

• Brand Name: ACCUSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC; 3070 orchard drive; san jose CA 95134
• MDR Report Key: 8489438
• Report Number: 2937094-2019-60459
• Device Sequence Number: 2758705
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: 03/14/2021
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 21861310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1