Model Number FB800R |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported to aesculap ag that a tuffier rib spreadr170x12543x53mm blds (part # fb800r) was used during a procedure performed on october 6, 2021.According to the complainant, the component of thumb screw, which controls the function of the blades opening and closing, was missing.The patient underwent an x-ray to confirm if part had detached at the surgical site.The surgery was delayed approximately twenty (20) minutes.The complaint device was returned to the manufacturer for evaluation.The adverse event / malfunction is filed under aic reference (b)(4).Involved component: fb800r-tuffier rib spreadr170x12543x53mm blds.
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Manufacturer Narrative
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Investigation results: visual inspection was performed.The instruments were forwarded to the manufacturing segment for examination.Excerpt from the report: "on the lobe screw, bv 439201 has broken off.This was soldered in and corresponded to the nominal at delivery.The solder connection is ideally evident at the point of breakage.On the production side, no defect can be detected." batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 1(5) x probability of occurrence 2(5) according to din en iso 14971 is still acceptable.Explanation and rationale: most likely, a mechanical overload due to incorrect preparation led to the breakage.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results a capa is not necessary.
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Event Description
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No updates required.
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Search Alerts/Recalls
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