Model Number PL430R |
Device Problems
Fracture (1260); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
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 (b)(4) that an endoscopic myoma fixation instrument (part # pl430r) was used during a total laparoscopic hysterectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a 5 millimeter (mm) laparoscopic myoma screw broke leaving a fragment embedded in a uterine fibroid inside the patient.Snapped inside uterine fibroid.The shaft of the instrument was removed immediately and the broken piece of the screw was removed shortly after.The event happened toward the end of the procedure and luckily did not cause harm to the patient.Roughly 20 mins operating time was added to the procedure due to the need to retrieve the broken instrument and ensure all parts were removed.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under (b)(4) reference (b)(4).
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Manufacturer Narrative
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Additional information - block a1, a2, a3, e1, e3.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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Manufacturer Narrative
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Investigation results: visual investigation: the instrument shows signs of tanning such as scuff marks and changes in colour of the plastic handle.The front spiral part of the instrument is broken off.The fracture surface of the instrument was visually examined.A tough bending force fracture was found, which can be attributed to an overload.A definitive fracture analysis is hardly possible, as the fracture surface of the missing broken part should also be considered.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaint against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 1(5) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the investigation results, no pores or inclusions could be found at the point of breakage.Conclusion and measures / preventive measures: based upon the investigation results, a clear root cause conclusion cannot be determined.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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Search Alerts/Recalls
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