MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

F24094860-1 : :2024/03/13.(user request and ter) event 1.The lens explodes due to excess heat.(it has a broken lens.) pae yes, tier 2, cvp1336c.Event 2.The xenon lamp is blown.: the thermal paste applied is insufficient for good heat dissipation.Pae yes, tier 2, cvp2012a.(ter) event 3.The lamp attached to the clv-s190 unit is not original from olympus.Pae no, tier 3, cvv.Event 4.The metal grate was broken.Pae no, tier 3, cvp4601y.Evaluation date: (b)(6) 2024.Evaluator: (b)(6).[factory investigation of the following events is required, in the following order: event no., event description, pae determination, tier, ufc].(user request and ter) event 1.The lens explodes due to excess heat.(it has a broken lens.) pae yes, tier 2, cvp1336c.Event 2.The xenon lamp is blown.: the thermal paste applied is insufficient for good heat dissipation.Pae yes, tier 2, cvp2012a.[factory investigation of the following events is not required, in the following order: event no., event description, pae determination, tier, ufc].(ter) event 3.The lamp attached to the clv-s190 unit is not original from olympus.Pae no, tier 3, cvv.Event 4.The metal grate was broken.Pae no, tier 3, cvp4601y.Containment measures: no (currently, no facts have been confirmed that suggest the possibility of the reported event expanding.).

Event Description

It was observed that during the device inspection, the xenon light source exhibited broken lens and the xenon lamp burst.There were no reports of patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Corrected fields: g3 (the aware date should be 12-march-2024 in the initial medwatch) h4 (should be july 28, 2015, in the initial medwatch) h10 of the initial report due to an inadvertent error: it was stated that ¿f24094860-1 :2024/03/13 event pae, tier, ufc (user request and ter) event 1.The lens explodes due to excess heat.(it has a broken lens.) pae yes, tier 2, cvp1336c event 2.The xenon lamp is blown.: the thermal paste applied is insufficient for good heat dissipation.Pae yes, tier 2, cvp2012a event, pae, tier, ufc (ter) event 3.The lamp attached to the clv-s190 unit is not original from olympus.Pae no, tier 3, cvv event 4.The metal grate was broken.Pae no, tier 3, cvp4601y evaluation date: 2024/03/13 evaluator: hiroyuki sekine [factory investigation of the following events is required, in the following order: event no., event description, pae determination, tier, ufc].(user request and ter) event 1.The lens explodes due to excess heat.(it has a broken lens.) pae yes, tier 2, cvp1336c event 2.The xenon lamp is blown.: the thermal paste applied is insufficient for good heat dissipation.Pae yes, tier 2, cvp2012a [factory investigation of the following events is not required, in the following order: event no., event description, pae determination, tier, ufc].(ter) event 3.The lamp attached to the clv-s190 unit is not original from olympus.Pae no, tier 3, cvv event 4.The metal grate was broken.Pae no, tier 3, cvp4601y containment measures: no (currently, no facts have been confirmed that suggest the possibility of the reported event expanding.)¿.Should be ¿the device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.¿ during the device inspection, it was observed that the lamp being used was not an olympus lamp and the thermal paste applied was not sufficient for good heat dissipation.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that each part was damaged due to excessive heat caused by the use of non-olympus lamps and incorrect application of thermal paste.The event can be prevented by following the instructions for use which state: "according to the instruction manual (ra6609) 6.1 replacement of the examination (xenon) lamp never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire.6.3 insertion of the lamp apply enough heat compound.If not, enough heat compound is applied, the heat can cause lamp ignition failures." olympus will continue to monitor field performance for this device.

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: XENON 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: 18947603
• MDR Text Key: 339322712
• Report Number: 3002808148-2024-02649
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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