Catalog Number 8065752451 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Retinal Injury (2048)
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Event Date 10/01/2021 |
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 physician reported a fresh retinal foramen was found during a final denting during a procedure.The foramina were treated with laser the eye was supplied with gas and patient had to camp.No hospitalization was required.The postoperative course was uncomplicated.Additional information received from the company representative indicating during the surgery all the 27g and 25g trocars were spontaneously leaking immediately after insertion leaked out of the valves.There were multiple products reported from the site and it is still unknown if this actual product is associated with the complaint.This report is second of the of three reports.This one represents the 25 gauge valved trocars.
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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 a fresh retinal foramen was found and the trocars were leaking after insertion; 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 reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported a fresh retinal foramen was found in direct projection onto the cannula of health care professional (hcp¿s) right hand during a final denting during a procedure.An additional intervention of laser was performed to treat the retinal foramen and the eye was supplied with gas and the patient had to camp.The foramina were entry side breaks (esbs).Additional information was received from the company representative indicating during the surgery all the 27g and 25g trocars were spontaneously leaking (leaked out of the valves) immediately after insertion.There were multiple products reported from the site as potentially involved the reporter could not provide clarification regarding which product is associated with this complaint.This report is the second of three reports for this patient.The two associated reports have reference numbers (b)(4).This report represents the pack with a 25 gauge valved trocars.
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Search Alerts/Recalls
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