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Model Number A22041A |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Full name of the facility: (b)(6).Full address of the facility: (b)(6).The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.The device was not repaired in the last year.Upon inspection and testing, it was observed, that the ceramic tip of the device was loose.Other observations for the device: sealing ring was damaged and the guide pin was missing.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
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Event Description
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As reported for this event by the customer, during reprocessing of the resection sheath device, the ceramic tip of the device became loose.There is no patient involvement.The previous therapeutic electrosurgical resection procedure was completed with the same device with no issues and no harm to the patient.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final 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 13 years since the subject device was manufactured.Based on the results of the investigation, it is likely the ceramic tip of the inner sheath being loose occurred due to wear and tear and/or improper handling by the customer.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿4 before use: 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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Search Alerts/Recalls
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