MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number	NGP680300
Medical Device Problem Codes	Computer Software Problem (1112); Fire (1245); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4 and a5: requested information and it was not provided.Section d6a: if implanted, give date: not applicable, as the system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the system is not an implantable device.Device evaluation: the phaco system was evaluated by a field service engineer (fse) and replaced the base charge control panel.The system is performing to specifications.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer reported that their whitestar signature system emitted smoke and shut down mid case.System restarted itself and displayed error codes.No patient injury and procedure was completed with backup system.No further information provided.
Additional Manufacturer Narrative
Corrected data - section h4, device manufacture date, mar 16, 2011.Section h10, additional data - through follow up it was determined that the machine started smoking before it came in contact with the patient.It was sequestered before it had patient contact.No further information provided.Section h6, component code - 765 - controller, 3032 - battery charger.Section h6, investigation findings, 180 - mechanical problem identified.Section h6, type of investigation, 3331 - analysis of production records, 4109 - historical data analysis.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 17671285
• Report Number: 3012236936-2023-02243
• Device Sequence Number: 6228871
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2011
• 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