Model Number SPL-S |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was received and evaluated.Evaluation confirmed the unit does not power up due to faulty plasma blend board.The d socket cover was missing.The unit is running on old version software (b)(4), and needs to be upgraded to (b)(4).The housing has multiple minor scratches.Based on evaluation findings, the root cause of the issue is likely attributed to users handling and or maintenance issue.
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Event Description
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It was reported that the device was found with broken transducer plug.The transducer would not stay activated.The issue occurred in the beginning of a nephro-percutaneous lithotomy procedure.The intended procedure was completed using another transducer.The event caused a ten minutes delay however, no patient harm or impact was reported.No user harm or injury was reported due to the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The reported failure is a known phenomenon and is produced as a result of damage to the transducer plug and/or receptacle.Damage to the receptacle is often incurred as a result of user error, often the user does not realize all connections are push/pull and instead the plug is twisted upon connection or removal.This action results in damage to the pins internal to the socket and may crack or damage the housing.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: connect the transducer to the generator by pressing the plug straight in.Caution do not twist or turn the plug.Connect the transducer to the generator by aligning the key way of the transducer connector with the key way slot on the transducer receptacle on the front panel.Push straight in.Caution do not twist or turn the plug.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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