MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC IDESIGN ADVANCED WAVESCAN STUDIO; EXCIMER LASER SYSTEM

Model Number	G300
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: when the customer reported the event to the technical support team the customer was instructed to shut the system down and unplug it from the wall.The customer reported that after doing it the smell went away.However, the customer plugged the system back into the wall power and the smell came back.Technical support told the customer to keep the system unplugged from wall power.A field service specialist (fss) was dispatched to check the system.Fss found black smoke residue inside the computer cover over the stack of hard drives.The fss also found the power supply connector from the computer power supply burnt and melted.Fss tried replacing the computer assembly but the computer was having issues with powering on and the user display was barely coming on and the fss was unable to see what was being displayed.Once everything was running correctly on the system the user display just went black.Fs installed a replacement aberrometer.Aberrometer was checked out, patient data was imported, human eyes were scanned and treatments transferred to the visx laser.Idesign system is operating to jnj specifications.A review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed.The system and its components met all specifications prior to being released.Equipment labeling was reviewed and the event is covered in that section.Preventive maintenance have not been performed on a routine basis.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, inc.Has been submitted.
Event or Problem Description
It was reported that the system was smoking and smelled like a ¿used firecracker¿.

• Brand Name: IDESIGN ADVANCED WAVESCAN STUDIO
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• MDR Report Key: 12137594
• Report Number: 3006695864-2021-08054
• Device Sequence Number: 3357161
• Product Code: LZS
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: G300
• Device Catalogue Number: 0110-2261
• 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: 06/10/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1