Catalog Number 8065751617 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2020 |
Event Type
malfunction
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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 it was difficult to insert the "vitrectomy" blade when inserting the trocar into the patient's eye and the trocar came out during the start of the procedure for a "hemo vitreous".The product was replaced with another one and the procedure was completed.There was no harm to the patient.
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Manufacturer Narrative
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Additional information provided in b.3.And b.5.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received from the surgeon who indicated the trocar came out of the insertion point when he was trying to insert the vitrectomy knife.He felt the trocar hole was too tight for the blade to enter.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation for the report of there was difficulty inserting the trocar and then it came out; therefore, the condition of the product could not be verified.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.Because a sample was not received at the manufacturing site and the device history record review indicated that the product was processed and released according to the product¿s acceptance criteria, the exact root cause for this complaint is unknown.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Non-conforming product is removed from the lot.Any nonconformances 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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