Catalog Number 0210118100 |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/12/2014 |
Event Type
malfunction
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Event Description
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It was reported that the interpulse handpiece with coaxial fan spray tips were being used in a procedure when they would not stay connected, requiring the surgeon to hold the tips on to complete the procedure.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.Device not yet received by manufacturer.
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Event Description
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It was reported that the interpulse handpiece with coaxial fan spray tips were being used in a procedure when they would not stay connected, requiring the surgeon to hold the tips on to complete the procedure.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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(b)(4) new (sealed) units were returned to the manufacturer for evaluation.All units were visually inspected.It was observed that all suction tubes were connected to tip inserts.A manual pull test was performed to suctions tubes and all ((b)(4)) suction tubes detached from tip inserts.Glue applied was not uniformly distributed thru the connected parts.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 devices were scrapped at the manufacturer.
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Search Alerts/Recalls
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