Model Number PL572T |
Device Problem
Unintended Ejection (1234)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/19/2021 |
Event Type
malfunction
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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 ligature clip 12 mag.= 144 pcs.(part # pl572t) was used during a laparoscopic hepatectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the cartridge detached.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
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Event Description
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Update: this case is associated with following mdr number 9610612-2021-00500 ((b)(4) pl574t), 9610612-2021-00539 ((b)(4) pl574t), and 9610612-2021-00501 ((b)(4) pl572t).
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Manufacturer Narrative
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Investigation results/ visual investigation: the investigation was carried out visually and microscopically with the digital microscope and the digital-camera.The investigator made a visual inspection of the products.Here they detected a broken off nose, wrong positioned clips, bent latches and deformations on the slider sheet.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.Conclusion and measures / preventive measures: according to the quality standard and dhr files a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.Investigations lead to the assumption that the cartridge is not engaged completely, there is an impairment of product functionality.This could led to deformed latches of the slider, to wrong positioned clips and a clip jam.A clip jam could also lead to a detached cartridge.Furthermore a too fast application of the cartridge can also led the clip jam and deform the slider sheet.Based upon our historically grown product experience and due to different simulation regarding a cartridge which is engaged not completely, this leads to the described errors.If the shaft / applier no longer conforms to the specification, this can also result in an incorrect engaged cartridge.According to the investigation results there is no capa reqeust necessary.
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Search Alerts/Recalls
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