Model Number GA513R |
Device Problem
Break (1069)
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Patient Problems
Death (1802); Failure of Implant (1924)
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Event Date 01/23/2019 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).When additional information is received a follow up report will be submitted.
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Event Description
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It was reported by the healthcare professional that the io tube exploded.During the surgical procedure of dr.(b)(6), the surgeon heard a loud noise after a strong pressure on the drill pen (motor), where it moved laterally, injuring the patient's left internal carotid artery.After that, the drill did not work any more and it was noticed that the hose was damaged, with abundant air outlet in its distal portion, near the pen, pretending to have exploded."was used the drill medially to the left carotid artery.The drill was working normally when uphill it was heard a loud noise coming from the pneumatic drill hose, with strong pressure on the pen, which moved laterally, injuring the left carotid artery." "we controlled the massive bleeding of the internal carotid artery on the left.The patient underwent arteriography, which showed occlusion of the left internal carotid artery.Performed decompensated craniectomy, to reduce risk of cerebral herniation, but the patient evolved with significant cerebral squamism, and evolved to brain death.".
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Manufacturer Narrative
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Aaesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: (b)(4).This is a preliminary investigation; additional information / investigation results will be provided in a supplemental report.Manufacturing site evaluation: (evaluation on-going - the device was not yet received but a photo was provided) investigation - no product was at hand, therefore a failure description is not possible and the investigation is incomplete.Batch history review- the device history records have been checked for the available lot number and found to be according to the specifications valid at the time of production.There is no indication for a material defect or manufacturing failure.No further complaints are registered against the lot number (52229776).Conclusion and root cause - the failure is most probably maintenance/wear and tear related.Rationale - due to the fact that we did not receive the air hose for investigation, a clear conclusion cannot be drawn to date.On the provided picture it was observed that the clamping ring is not on the intended position; an extract of the technical drawing from ga513r shows the correct positioning.It is possible that the clamping ring loosened during the surgery which resulted in the sudden air outlet.Furthermore, according to the instructions for use (ifu), maintenance must take place at least once per year: section 7 maintenance - to ensure reliable operation, the product must be maintained at least once a year in accordance with the maintenance labeling; see maintenance label for technical service, please contact your national b.Braun/aesculap agency, see technical service no information regarding a maintenance/repair could be found in the database.A maintenance due date can be seen on the picture, "2017-09", which means that maintenance should have taken place in (b)(6) 2017.Therefore we assume that the failure is maintenance/wear and tear related.To date, we have not received the complained product but according to the subsidiary it will be provided.After receipt, an investigation will follow.
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Manufacturer Narrative
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This is a preliminary investigation; additional information / investigation results will be provided in a supplemental report, if available.*the initial report was filed on behalf of aesculap ag (manufacturer, registration no.(b)(4)) under exemption e2014018 by aesculap inc.((b)(4)).Although this exemption is no longer in effect, due to the nature of the complaint, aesculap inc.Will continue to follow for any updates.Manufacturing site evaluation: investigation: we did receive the products, however, to date it is unclear if a detailed investigation (disassembly of the parts) is allowed.If we receive the approval by the hospital, a further investigation report will follow.Failure description: optically, the products are in a good but used condition.The clamping ring on the side of the handpiece connection at the air hose is not in its intended position; the labeling regarding the required maintenance shows "(b)(6) 2017".Batch history review: the device history records have been checked for the available lot number and found to be according to the specifications valid at the time of production.There is no indication for a material defect or manufacturing failure.No further complaints are registered against the lot number (52229776).Conclusion and root cause: the failure is most probably maintenance/wear and tear related.Rationale: a detailed investigation could not take place so far due to a missing approval.The optical examination of the provided air hose shows that the clamping ring which is used to crimp the air hose is not on its intended position.It is possible that the clamping ring loosened during the surgery which resulted in the sudden air outlet as mentioned in the initial complaint description.Furthermore, according to the instructions for use (ifu), maintenance must take place at least once per year.No information regarding a maintenance/repair could be found in the database.A maintenance due date can be seen on the picture, "(b)(6) 2017", which means that maintenance should have taken place in (b)(6) 2017 and that it was overdue for 16 months (the incident happened in (b)(6) 2019).Therefore we assume that the failure is maintenance/wear and tear related.
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Manufacturer Narrative
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*the initial report was filed on behalf of aesculap ag (manufacturer, registration no.(b)(4)) under exemption e2014018 by aesculap inc.(importer, registration no.(b)(4)).Although this exemption is no longer in effect, due to the nature of the complaint, aesculap inc.Will continue to follow for any updates.Concomitant devices (reported separately): hilan pneumatic perforator driver.Foot control for pneumatic drivers.Hi-line xs angled hand piece ii.This is a follow-up report due to the fact that we did receive approval for disassembly/investigation of the provided products.Manufacturing site evaluation: investigation - we did receive the products.The investigation was carried out by aesculap technical services (ats).Failure description - optically, the products are in a used condition.The air hose is in a used condition.A functional test could not be carried out due to its defect.The clamping ring on the hand piece side is not in the proper position.After disassembly of the hand piece side, it can be found that the inner air hose is chipped off.The spring (bend protection) is broken.The unlocking sleeve is deformed and does not switch back to its intended position by itself.It is most likely that an inappropriate usage led to the breakage of the spring.Due to the resulting sharp edges of the spring, the coating at the inner hose was probably damaged which led to chipping.Due to chipping of the inner hose and the resulting over-pressure, the outer air hose lost its fixation.The damage of the unlocking sleeve indicates a fall or impact damage.Also, according to the instructions for use (ifu), maintenance must take place at least once per year.No failure could be detected at the perforator driver.Maintenance exceeded "2017-09".Functionally, the foot control is in order.However, wear and tear can be found.A maintenance is recommended.The hand piece was delivered in 2008.A maintenance did not take place since that date according to our database.Running noises can be detected as well as rough tool locking.The interior and ball bearings are stained which are a consequence of wear and tear.A yearly maintenance is recommended for that product.Batch history review- the device history records have been checked for all available lot numbers and found to be according to specifications valid at the time of production.There is no indication for a material defect or manufacturing error.Conclusion and root cause - the failure is most likely usage/wear and tear (lack of maintenance) related.Rationale - refer to investigation above.
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Search Alerts/Recalls
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