Catalog Number 8065751196 |
Device Problems
Break (1069); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that the handling part on the probe cutter broke and a sound was heard during surgery.The product was replaced with another one, but the same issue occurred to the following 2 probes.The surgery was discontinued with the patient introduced into another hospital.It is unknown whether or not the surgery was completed.Additional information has been requested.
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Event Description
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Additional information was provided by the customer who indicated the procedure was completed on the right eye by using a vitrector fixing out of the bag.
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Manufacturer Narrative
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Three opened and two unopened probes were received.The customer reported on (b)(6) 2021 the three probes were broken.The expiration date of the customer reported lot is (b)(6) 2017.The review of the lot number provided indicated the product was used beyond its expiry date, therefore the received probes were not evaluated by the manufacturing site.A review of the lot number provided indicated the product was used beyond its expiry date.No specific action with regard to this complaint was taken by the manufacturing location because the complaint sample exceeded its expiration date and should not have been used.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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