Model Number IPN048387 |
Device Problems
Break (1069); Optical Problem (3001)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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Customer complaint reported as: "happened at the otorhinolaryngology anaesthesia department.During a laryngoscopy, there was no light on the blade.Afterwards, the handle was tested and it worked.When inspecting the blade, we observed that the optic fiber was broken(whereas there was no fall of the device as far as we know).Clinical consequences: no consequence for the patient." it was reported the issue was detected during the test of the device.
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Manufacturer Narrative
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Qn#(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and small broken pieces were observed in the packaging.It was also stated that the spot welding joint was intact.The manufacturer also reports that this product family is inspected 100% prior to shipment so it is confirmed that the device left the manufacturing site fully functional.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the investigation performed, the complaint is confirmed.It seems that for some reason it sustained unexplained physical damage.The product cannot withstand the unexplained external impact.Because of the increasing trend in greenlite breakage complaints, a capa has been opened to address this issue.
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Event Description
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Customer complaint reported as: "happened at the otorhinolaryngology anaesthesia department.During a laryngoscopy, there was no light on the blade.Afterwards, the handle was tested and it worked.When inspecting the blade, we observed that the optic fiber was broken(whereas there was no fall of the device as far as we know).Clinical consequences: no consequence for the patient.".It was reported the issue was detected during the test of the device.
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Search Alerts/Recalls
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