Associated medwatches: other cartridges reported separately manufacturing evaluation: investigation: we received a complaint about 6 challenger cartridges from four batches.Six broken 5 mm cartridges are available for investigation decontaminated.All were broken and deformed; the deformation may have been caused by reprocessing which is necessary to carry out an investigation.The pl606r is an applicator for the 10 mm cartridges, and we did not receive the 5 mm applicator.Visually, all cartridges showed a clip jam, 2 tips were broken off.Once cartridge was fractured approximately in the middle of the device.The analysis all fracture patterns illustrated forced fractures due to overload.No pores, inclusions or foreign bodies could be found on the points of rupture.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production.No similar incidents have been filed with products from the batches 52499423, 52496374 and 52501915.Two similar incidents have been filed with products from the batch 52491012.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the problem is most likely related to insufficient usage.Rationale: according to the quality standard and device history records (dhr) files a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation during mounting the cartridges on the applicator.There is a possibility for a too fast application, and therefore a proper transport of the clips can no longer be guaranteed.
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It was reported that there was an intraoperative issue with challenger clips.During an unspecified procedure, the clips were misfiring.The facility was concerned about a possible material defect or processing errors.Additional information was not provided, although it had been requested.
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