It was reported to aesculap inc.That a finochietto-burford rib spreader (part # (b)(4)) was used during a thoracic surgery performed in (b)(6) 2020.According to the complainant, during the procedure, the surgeon was unable to open or close the chest retractor after it was placed inside the patient.Reportedly, the patient experienced a major bleed of the pulmonary artery, and because the device was not able to be opened, the surgeon was not able to fully access the bleed site to sew the wound.After approximately fifteen (15) minutes of struggling with the device, it was able to be freed and removed.The surgeon was then able to address the bleed and successfully complete the procedure.The complaint device was returned to the manufacturer for evaluation.Additionally, the device was noted as being approximately two (2) years old.The patient's condition was noted as being "fine" at the conclusion of the procedure.Additionally, the reporter confirmed that the patient was stable post operatively.The adverse event is filed under aag reference (b)(4).
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Investigation results: visual investigation: the instrument provided is in a used condition.Friction marks can be found at the gliding surfaces caused by insufficient reprocessing.Due to this damages, a proper function of the instruments are no longer given.To avoid metal-on-metal friction instructions for reprocessing must be observed.This is also labelled on the instrument directly.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results root cause was found to be insufficient reprocessing.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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