(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: was the suture found damaged/ broken/fray in the package? no, the suture damaged during operation.Was the suture detached from the needle found in the package? no, the suture detached from the needle during operation.What was used to complete the procedure? used the new pack of suture.What is the patient's condition? n/a.What is the procedure's name? cataract surgery.What is the procedure date? (b)(6) 2020.What is the event date? (b)(6) 2020.Investigation summary: it was reported detached needle.One picture was provided for analysis.Upon visual inspection of the pictures, one open box of product code w1718, lot mpr941 could be observed.However, as no needle or suture were noted; no conclusion could be reach as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot number mpr941, and no non-conformance's were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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