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

Model Number	0010-6122
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the surgeon was lasering the patient's ear; the end of the fiber burnt off and became detached.The surgeon confirmed that the detached fragment had not remained in the patient¿s ear by looking through the microscope and a 30-degree scope.There was no patient injury due to this event.No further information is available.

• 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: 7734935
• Report Number: 2937094-2018-00816
• Device Sequence Number: 1018778
• Product Code: GEX
• UDI-Device Identifier: 00878953000053
• UDI-Public: 00878953000053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 11/07/2020
• Device Model Number: 0010-6122
• Device Catalogue Number: 0010-6122
• Device Lot Number: 21349345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1