The customer reported to olympus that the resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath had the ceramic tip loose.The issue was found during reprocessing for a diagnostic hysteroscopy that was completed with a similar device and no delay.There were no reports of patient harm.
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the loose ceramic tip could not be identified.However, it¿s likely the cause is related to thermo-mechanical fatigue, wear and tear, or improper handling (impact/shock).The suggested event is detectable by handling the device in accordance with the following section of the instructions for use: chapter 4: warning: infection control risk: properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.4.1, inspection and testing: inspecting the product: visually inspect the product.Make sure that it has: no corrosion; no dents; no scratches.Ceramic insulation at distal end: visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).Warning: risk of injury: impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.Olympus will continue to monitor field performance for this device.
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