Catalog Number C-HSK-3043 |
Device Problems
Entrapment of Device (1212); Retraction Problem (1536); Fitting Problem (2183)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be pulled out normally and was left in the predevice.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Internal complaint # tw (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Only the seal was returned to the factory.Signs of clinical use with evidence of blood were observed on the seal.The seal appeared intact and unraveled and remained attached to the tension spring assembly.The tether also remained uncut.An evaluation of the reported failure fitting problem cannot be performed since the loading and delivery devices were not returned.Based on the device returned being incomplete, the reported failure fitting problem was not confirmed.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using hs iii proximal seal sytem4.3mm.They found that the protective umbrella of the proximal heartstring could not be pulled out normally and was left in the predevice.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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