Catalog Number 0210114100 |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/19/2014 |
Event Type
malfunction
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Event Description
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It was reported that the interpulse handpiece with coaxial high flow tip was being used in a total knee replacement procedure when the tip fell off and into the surgical site.The physician removed the tip by hand and the procedure was completed successfully, with no patient or user injuries, and no adverse consequences.
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Manufacturer Narrative
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A follow up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer.
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Event Description
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It was reported that the interpulse handpiece with coaxial high flow tip was being used in a total knee replacement procedure when the tip fell off and into the surgical site.The physician removed the tip by hand and the procedure was completed successfully, with no patient or user injuries, and no adverse consequences.
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Manufacturer Narrative
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One (1) tip was returned to the manufacturer for evaluation.The suction tube was found detached from the tip insert / base.Glue residues were observed in the suction tube and the tip insert, but not evenly or uniformly distributed through the bonding areas.The most probable root causes for this condition can be associated, but not limited to: the tip might break or fall off if the assembly of the tip is improperly bonded (excess/less adhesive or solvent) producing weak or brittle bonding between parts.Incorrect assembly process (not enough insertion of suction tube) or too much force applied during assembly at the manufacturing process.Possible application of too much force during the tip assembly to the irrigation handpiece at the set-up stage in the operating room or during device usage.Poor gap design for mating parts (suction tube and tip insert).The reported event was confirmed.The device was scrapped at the manufacturer.
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Search Alerts/Recalls
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