Catalog Number 8065982465 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A sample has been received and in-house testing is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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An ophthalmic surgeon reported that prior to a surgical procedure, upon opening the package it was noted that the tip of the knife was chipped.The case was initiated and completed using an alternate knife.There was no patient involvement.
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Manufacturer Narrative
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One opened slit knife was received in blade protector tray for the report of chipped tip of slit knife.The returned sample was visually inspected and was found non-conforming with a damaged tip and a damaged cutting edge.Penetration testing could not be performed due to the damage of the sample.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there is one additional complaint associated with the lot for the reported issue.The exact root cause could not be determined from the investigation performed.The damage to the returned sample is consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when product is improperly removed or inserted after use, or improper handling, or contact with another instrument during surgery or set-up.(b)(4).
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Search Alerts/Recalls
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