MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

Device Problems Failure to Power Up (1476); Installation-Related Problem (2965)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.If additional information becomes available at a later time, this report will be supplemented accordingly.

Event Description

The field service engineer was informed by the user facility that the visera 4k ultra high definition xenon light source did not turn on prior to procedure.The light source was reportedly connected to the electrical network at the wrong voltage.The equipment is only 127 volts and was turned on at 220 volts attributing the equipment to burn out.There was no patient involvement and no adverse outcome to the procedure.

Manufacturer Narrative

The correct aware date is july 30, 2021.The investigation is ongoing; therefore, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

The field service engineer (fse) was scheduled to perform a preventative action on the user facility's equipment on july 1, 2021.On july 30, 2021, the fse visited the user facility and became aware that the visera 4k ultra high definition xenon light source did not turn on prior to procedure.The light source was reportedly connected to the electrical network at the wrong voltage.The equipment is only 127 volts and was turned on at 220 volts attributing the equipment to burn out.There was no patient involvement and no adverse outcome to the procedure.The device was replaced and the intended procedure was completed.The device evaluation is pending as the unit is expected to be returned for evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and evaluation results of the suspect device.An olympus technician completed a full evaluation of the subject device.Equipment does not turn on, as the internal network filter and power supply are burned out.The emergency lamp is not working and the zenon lamp is not the original olympus.Found two loose screws inside the equipment that are not part of the equipment, both may have passed through the grid that allows ventilation of the equipment.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the cause of the visera 4k ultra high definition xenon light source not powering on is likely from the burning of the internal board and power supply.The cause of the burnout of the power supply circuit is likely from the user mistakenly turning the power on with improper voltage which resulted in the board to burnout.The cause of the emergency lamp not working is likely from a faulty power supply circuit.The specific root cause of the faulty power supply circuit is likely from the user mistakenly turning the power on with improper voltage which resulted in the board to burnout.The specific root cause of the two loose screws in the equipment could not be determined at this time.The following information is stated in the instructions for use regarding the connection which may have prevented the event: "specifications power requirements voltage (ac) (see electrical rating plate): 120 v, frequency 50/60 hz, input: 6 a, voltage fluctuation within 10%" olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 4K UHD XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12322012
• MDR Text Key: 280580276
• Report Number: 8010047-2021-10235
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

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
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 11/08/2021
• Supplement Dates FDA Received: 08/24/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1