Model Number HEMOPRO2 ADAPTOR |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure using hemopro2 adaptor, they had determined that the vh-4020 was processed through sterile processing and the root cause of the intermittent power during vessel ligation.This was not done on a patient, no patient involvement.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure using hemopro2 adaptor, they had determined that the vh-4020 was processed through sterile processing and the root cause of the intermittent power during vessel ligation.This was not done on a patient, no patient involvement.
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Manufacturer Narrative
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Internal complaint number: (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.A lot number was not provided and the specific product lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.The device was returned to the factory for evaluation on (b)(6)2020.An investigation was conducted on (b)(6)2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The device was evaluated for connector function.The cable was able to provide a secure connection that connected and disconnected without incident.An electrical evaluation was performed.A pre-cautery test as was performed per the instruction for use (ifu) with a reference hemopro 2, adapter cable and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced steam and heat during 5-second activations and shut off when the toggle was released.A polyfuse electrical test was performed with the same reference power supply, adapter cable and hemopro 2; the polyfuse successfully shut off power to the heater after prolonged periods of time and activated after the device cooled.This adaptor was sterilized, when it is not supposed to be sterilized.Based on the returned condition of the device, there were no issues found with the product.
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Search Alerts/Recalls
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