Model Number PL430R |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
Injury
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Event Description
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This report is submitted in reference to mw5119092.It was reported to aesculap inc.That an endoscopic myoma fixation instrument (material # pl430r) was used during a procedure performed on (b)(6) 2023.According to the complainant, during the surgeyer, the tip of myoma screw broke.Fragments detached into the patient, but all were successfully retrieved.The complaint device was returned to the manufacturer for evaluation.Patient harm was unknown.Additional information was requested, but has not yet been made available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should additional information / investigation results become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information: b1 and b2 - report type and outcome.B5 - patient harm updated.D9 - product return date.H1 - type of report.H3 - evaluation.H4 - manufacture date.H6 - codes updated.Investigation result: investigator carried out the pictorial documentation visually and microscopically.The instrument is in a worn condition, the working end of the device has fractured about 40mm after the distal end, the fragment is present for examination.The fracture surface of shows no abnormalities like blowholes of foreign particle inclusions.Due to the small dimension/diameter of the device, a detailed fracture surface analysis is difficult.Due to that circumstance there are no clear hints regarding arrestlines (hints for fatigue fracture) or clearly signs of a forced fracture.Device 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 current failure rate is within the risk analysis and therefore acceptable according to according to din en iso 1497; severity was 3(5) and probability 1(5).Conclusion and preventive measures: based upon the above mentioned investigation results, a definitive root cause for the reported issue could not be established.Based upon investigation results, a capa is not necessary.
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Event Description
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Update: patient harm was confirmed as additional medical intervention.The adverse event is filed under aag reference (b)(4).
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Search Alerts/Recalls
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