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Model Number EIS-CFR-25 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The exact cause of the reported event could not be determined at this time.However, based on similar events the most probable cause of the reported event could be attributed to the operator¿s technique.The instruction manual provides warning to mitigate the risk of patient harm and device damage which states, ¿always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath¿s insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.¿.
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Event Description
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Olympus was informed that during a therapeutic resection procedure, the ceramic sheath broke and fell into the patient.The device fragment was retrieved.There was no unexpected bleeding reported.The patient did not require any additional procedures or hospitalization.The procedure was prolonged by approximately 15 minutes.The intended procedure was completed.There was no patient injury reported.
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Manufacturer Narrative
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This supplemental report is being submitted to report the device evaluation.The device was returned to the service center for evaluation.The black beak was found to be partially broken and the broken piece was missing, not returned.The beak is about 30 degree angle and in the cylinder shape; therefore, the missing fragments could be variable in length, and approximately 35 percent of the beak is missing.A visual inspection under a microscope revealed 2 long cracks on the beak.There are also small dents on the distal portion of the inner sheath tube.The red dot on the locking ring is missing.However, the device passed mechanically inspection as its lock ring and release button functioned correctly when checked with the test working element eiwe.Based on the investigation findings, the damage to the ceramic beak is likely due to physical impact caused by mishandling.The sheath could have come into contact with a hard surface or being dropped by user.
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Manufacturer Narrative
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This supplemental report is being submitted to report additional information and lot number.Additional review of manufacturing and production records show that the that the ceramic material switched better fracture toughness, elasticity modulus, flexural strength, heat shock resistance, and thermal conductivity.Eliminated the holes as stress concentrators.Eliminated the contact between the metallic tube and the ceramic tip (dimple into hole.) the new ceramic tip resists better to chipping caused by drops, bending/torque/tension stress, and thermal differential.The new material formulation is not marred by the current material¿s propensity to low temperature degradation leading to microcracking.
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Search Alerts/Recalls
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