MAUDE Adverse Event Report: FS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	20005D
Medical Device Problem Codes	Computer System Security Problem (2899); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a software issue occurred during the treatment.The procedure was cancelled and treatment not completed on that same visit.No other information was provided.
Additional Manufacturer Narrative
Field service visited site to service the system and was unable to reproduce reported issue.The system meets specifications.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/ treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision has been submitted.

• Brand Name: FS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• MDR Report Key: 12755106
• Report Number: 2020664-2021-08048
• Device Sequence Number: 1442311
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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 Model Number: 20005D
• Device Catalogue Number: 20005D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/04/2021
• Date Device Manufactured: 07/30/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1