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 02/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with pl572t - ligature clip 12 mag.= 144 pcs.According to the complaint description, the clips were used for esophageal surgery.When the doctor tried to clip it in the chest cavity, the cartridge came off and fell into the chest cavity.The patient had no infection reported.An additional medical intervention was necessary.Additional information was not provided nor available.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under (b)(4).
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Event Description
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The adverse event is filed under aag reference (b)(4).
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Manufacturer Narrative
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Investigation results: visual investigation: here we found deformed latches/tips of the slider sheet and clip jams.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints 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: there are no hints of a pre-damage or similar.Investigations leads to the assumption that the titanium clip cartridge was engaged not completely or was damaged during inserting.If the cartridge is engaged not completely or was damaged during inserting, there is an impairment of product functionality.This could lead to deformations on the slider sheet, to clip jam and can cause the titanium clip cartridge to jump off.Possibly a damaged clip applicator due to a deformed push rod or something similar could be another cause for a detached titanium clip cartridge.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 investigations results, a corrective action and preventive action (capa) has been initiated.
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Search Alerts/Recalls
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