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Model Number BL5115-2 |
Device Problem
Failure to Infuse (2340)
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Patient Problem
Capsular Bag Tear (2639)
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Event Type
Injury
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Manufacturer Narrative
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The device has not been returned.Manufacturing and sterilization records for this device were reviewed and found to be acceptable.The investigation is ongoing.See related report: 0001920664-2023-70036.
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Event Description
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The user facility in france reported that during the procedure the irrigation was suddenly interrupted resulting in chamber movement and drooping of the eye.A capsular rupture occurred and an anterior vitrectomy was required.When the vitreotome was connected to the pipes, lack of infusion was noticed again.The cassette was changed and again no infusion occurred.A third cassette was used and the irrigation worked.The surgeon was able to proceed with resolving the capsular rupture and placement of the implant.This report is for the second cassette.
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Manufacturer Narrative
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One opened bl5115-2 pack from lot x3374 was returned.Visual inspection found the assembly dirty with fluid in the lines.A functional test was performed using a stellaris elite.The collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test and primed.In addition, the irrigation flow was tested using three methods of control.The touch screen on/off switch, the foot controller on/off switch, and the pinch clamp on the tubing.The irrigation did start and stop when prompted by two of the three methods used.However, when initiating "continuous irrigation" on the touch screen, the fluid does not flow from the iv bottle down and out the end of the irrigation tubing.Further testing found that air does not flow or has a diminished air flow through the blue-striped airline.This sample has been sent to the vendor for evaluation.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.See related report: 0001920664-2023-70036.
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Manufacturer Narrative
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Correction to d9 from: 01-may-2023 to: 01-aug-2023.H10 ¿the previous report included information not related to this incident.Therefore the last reported evaluation results do not apply¿ evaluation completed.Two opened packs were returned.Visual inspection found the assemblies dirty with fluid in the lines.Both assemblies were returned with the tubing iv spike inserted into balanced salt solution bottles.A functional test was performed using a stellaris elite.The collection cassettes were captured and recognized by the system.The assemblies passed the self-vacuum test, and primed.In addition, the irrigation flow was tested using two methods of control.The touch screen, the on/off switch, and the foot controller.The irrigation did start and stop when prompted by the foot controller.However, when initiating "continuous irrigation" on the touch screen, the fluid does not flow from the iv bottle down and out the end of the irrigation tubing.Further testing found that air does not flow or has a diminished air flow through the blue-striped airline.The supplier reported there is some air flow and there are other potential reasons that may affect irrigation, such as kinked tubing, blocked filter, detached manifold and detached tubing, so it cannot be definitively stated that the occlusion is the only source of the flow issue reported.The root cause for the flow issue can not be determined because there are too many potential causes for reduced flow.No corrective action is required.
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Search Alerts/Recalls
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