MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HALOGEN LIGHT SOURCE

Model Number	CLH-SC
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered faulty lamp, poor connection due to deterioration of the lamp connector, lamp contact pin deformation and output connector (light guide connection part) was loose due to wear.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, lamp doesn¿t light up on the halogen light source.There were no reports of patient harm associated with this event.
Event or Problem Description
The customer confirmed the device was inspected before use.The event occurred during an unknown diagnostic and therapeutic procedure.After checking the connection part of the lamp, it lit up, so there was no effect on the treatment.There was a ten (10) minute delay reported.The procedure was completed without the need to change equipment.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer follow-up.B3/b5: updated within information from the customer.The device history record was unable to be reviewed as the subject device was manufactured over 15 years ago.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely the event occurred due to the connection failure caused by the deterioration of the lamp connector.However, the specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• Brand Name: HALOGEN LIGHT SOURCE
• Common Device Name: HALOGEN LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15853765
• Report Number: 3002808148-2022-04567
• Device Sequence Number: 17443809
• Product Code: FAJ
• UDI-Device Identifier: 04953170024467
• UDI-Public: 04953170024467
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K993041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: CLH-SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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