MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC FS LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	20005D
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During service visit, field service engineer (fse) started to bootup the computer and during program system stopped due to oscillator temp being out of spec.Fse noticed smell coming from the delivery system.Fse removed the covers off delivery system and restarted laser system and then could notice slight bit of smoke from the upper right side of the gantry board.The system was turned off and the covers were put back on.
Additional Manufacturer Narrative
Operator device (other) - the system is currently not in use at a medical facility.This system has been in an uncontrolled warehouse and is not being used or owned by a medical office.Device evaluation: field service engineer (fse) informed customer that parts would be needed to proceed and get machine to startup with the cost of (b)(4) for the system to meet spec.Customer made a decision not to fix the system.This system has been in an uncontrolled warehouse for the last 7 years and still is.It is not in a medical office and was not being used or owned by a medical office.Manufacturing records review: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.Conclusion: as a result of the investigation and based on limited information available, it cannot be determined if there is a product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: after the completion of the investigation the field service engineer (fse) has concluded that the system is non repairable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: h4: correction: in initial report, the manufacturer date provided was inadvertently reported as 04/08/2008, however the correct date is 04/14/2008.Additional information: a record review was performed.A product malfunction was identified as device failed to function as intended however, pm's are not performed on a routine basis with the last pm performed on 12/05/2016.A review of the device history record (dhr) showed that there were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.A product deficiency review was performed and there is no product deficiency identified.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.Conclusion: based on the information obtained, product deficiency cannot be confirmed.No further investigation is required all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: FS LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 16143403
• Report Number: 3012236936-2023-00102
• Device Sequence Number: 6559232
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2023

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: Other
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/01/2023; 03/14/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/27/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2008
• 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
• Patient Sex: Unknown