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	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a prostate procedure, the fiber tip was broken upon opening.It is unknown how the case was completed.No patient and user complications were reported due to this event.

• 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: 7711296
• Report Number: 2937094-2018-00790
• Device Sequence Number: 1015929
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• 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): 07/03/2018

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: 11/27/2020
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 21436668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1