Catalog Number 004551004 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer reported prior to patient use, the blade cannot be tightly attached to the laryngoscope handle because a metal piece is bent at the blade's clamping device, preventing contact with the light source.
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Manufacturer Narrative
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(b)(6).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 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 of the lot number of the sample received was reviewed and no issues that could have contributed to the reported failure were 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 reported prior to patient use, the blade cannot be tightly attached to the laryngoscope handle because a metal piece is bent at the blade's clamping device, preventing contact with the light source.
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Search Alerts/Recalls
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