It was reported that there was an issue with the product pl579t - challenger ti-p ml-ligat.Clips 12 cartr.According to the complaint description, the clips did not discharge but accumulated among themselves.With increasing accumulation, the charger jumped off.The magazines therefore had to be recovered from the abdominal cavity.Additional medical intervention was necessary.There was a surgery delay of 20 minutes.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
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Additional information: b5 - updated, d9 - product return date, h3 - yes, evaluation, h6 - codes updated.Investigation results: during visual inspection of the concerned complaint sample, a clip jam and deformation on the slider sheet was noted.Three (3) other empty samples had been received without clips.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to specifications valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered eportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: the exact cause could not be determined.It is necessary to ensure that the cartridge is fully engaged and not damaged during insertion.Furthermore, as mentioned in the instruction for use (ifu) with the internal number (b)(4), change no.(b)(4) to prevent a clip jam, do not interrupt the loading process e.G.If the clip application sequence is carried out at excessive speed.On the basis of the available information as well as 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 investigation results, a capa with the internal reference number (b)(4) had been initiated.At the present time, no further actions are necessary.
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