It was reported that during an unidentified procedure the tip of the reusable laryngeal mask cracked and broke off.After multiple good faith attempts the reporting facility was unable or unwilling to provide additional information related to the incident.No impact or adverse effect to a patient or to the unidentified procedure was reported to the manufacturer.A sample was returned to the manufacturer for evaluation.The sample appeared to be in used condition and the plastic connector was found to be cracked and broken off.Cracking of the plastic connector may be due to high temperatures during sterilization.Without additional information related to product handling, use, sterilization, and amount of reuse, a root cause for the reported incident was unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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