MAQUET CARDIOVASCULAR LLC HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number HEMOPRO2 EXTENSION CABLE |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/07/2020 |
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 an endoscopic vein harvesting procedure, hemopro2 extension cable were unable to get power to the jaws.Finally this was accomplished by the perfusionist bending the adapter cable which allowed power to go to the jaws.They had to hold and bend the cable through the rest of the evh procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable were unable to get power to the jaws.Finally this was accomplished by the perfusionist bending the adapter cable which allowed power to go to the jaws.They had to hold and bend the cable through the rest of the evh procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Updated sections: g4,g7,h2,h3,h6,h10.Internal complaint number: (b)(4).The reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.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 12dec2020.An investigation was conducted on 28dec2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The extension cable was observed to be intact, with both collars attached to the cable.A mechanical evaluation was conducted using a reference adaptor, power supply and hemopro 2 device.The cable was able to be connected to the adaptor with no physical or visual difficulties.The reference harvesting device was attached to the cable with no physical or visual difficulties observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 evh tool, reference adapter and reference power supply set at level 3.0.The device did not pass the pre-cautery test.The power supply did not emit an audible beeping sound and the evh reference tool did not produce steam and heat.Based on the returned condition of the device and the results of the evaluation, the reported failure "failure to deliver energy" was confirmed.We cannot confirm the age, sterilization or usage history of this reusable, non-serialized oem device for which the lot number was not provided.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable were unable to get power to the jaws.Finally this was accomplished by the perfusionist bending the adapter cable which allowed power to go to the jaws.They had to hold and bend the cable through the rest of the evh procedure.The hospital did not report any patient effects.
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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.We cannot confirm the age, sterilization or usage history of this reusable, non-serialized oem device for which the lot number was not provided.The device was returned to the factory for evaluation on 12dec2020.An investigation was conducted on 28dec2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The extension cable was observed to be intact, with both collars attached to the cable.A mechanical evaluation was conducted using a reference adaptor, power supply and hemopro 2 device.The cable was able to be connected to the adaptor with no physical or visual difficulties.The reference harvesting device was attached to the cable with no physical or visual difficulties observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 evh tool, reference adapter and reference power supply set at level 3.0.The device did not pass the pre-cautery test.The power supply did not emit an audible beeping sound and the evh reference tool did not produce steam and heat.An engineering evaluation was conducted that identified the root cause of the reported failure "failure to deliver energy".There is a build up of particulate around the connector pins, which failed to carry current to the harvesting tool.Based on the returned condition of the device and the results of the evaluation, the reported failure "failure to deliver energy" was confirmed.
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