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Catalog Number 004551004 |
Device Problem
Break (1069)
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Patient Problem
Tooth Fracture (2428)
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Event Date 03/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer reported the device broke in half during intubation.The blade hit tooth '9 and it became loose then fell out in pacu.It was reported that no medical intervention was required and the patient was "fine" at the time of this report.Medwatch form received and states: "a middle-aged female with history of elevated blood pressure and svt.Undergoing procedure ankle/foot arthrodesis/fusion and bone graft.Anesthesia assessment identified a loose #9 tooth and warned the patient of risk.During intubation, the crna advanced the laryngoscope and it snapped in half, causing the front tooth of the patient to loosen/dislocate from gum.In pacu, the tooth came out.".
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Manufacturer Narrative
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(b)(4).Medwatch uf/importer report#: (b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the blade welding joints were broken although the metal was diffused properly at the welded joints.The manufacturer also reports that this product family is inspected 100% for functional testing (engagement, disengagement, light testing on handle) prior to shipment so it is confirmed that the device left the manufacturing site fully functional.Strength of spot-welded joint cannot be tested for 100% which could lead to the possibility of shipping product with a weak spot-welding joint.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.The blade was broken into two parts from the welded joints.The root cause is listed as manufacturing related.A capa has been opened to address this issue.
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Event Description
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Customer reported the device broke in half during intubation.The blade hit tooth '9 and it became loose then fell out in pacu.It was reported that no medical intervention was required and the patient was "fine" at the time of this report.Medwatch form received and states: "a middle-aged female with history of elevated blood pressure and svt.Undergoing procedure ankle/foot arthrodesis/fusion and bone graft.Anesthesia assessment identified a loose #9 tooth and warned the patient of risk.During intubation, the crna advanced the laryngoscope and it snapped in half, causing the front tooth of the patient to loosen/dislocate from gum.In pacu, the tooth came out.".
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Search Alerts/Recalls
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