MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC. ENDOSTAT; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-0622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed that the fiber distal end exhibits no sign of usage.The connector is detached from fiber.The fiber exhibits no signs of melting at break location.The fiber was tested with hene laser fixture, aim beam is visible at connector opening.An evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
Analysis of the returned device found that the fiber connector detached from the fiber and aim beam is visible at connector opening.There was no patient or user impact.

• Brand Name: ENDOSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS INC.; 3070 orchard drive; san jose CA 95134
• MDR Report Key: 8251439
• Report Number: 2937094-2018-60330
• Device Sequence Number: 1594138
• Product Code: GEX
• UDI-Device Identifier: 00878953000107
• UDI-Public: 00878953000107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• 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): 01/15/2019

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: 05/03/2021
• Device Model Number: 0010-0622
• Device Catalogue Number: 0010-0622
• Device Lot Number: 22075870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1