Samples received: 4 open and used samples.Analysis and results: there are no previous complaints of the same code-batch.There are no units in our stock.We have received four open and used samples for analysis.1) visual inspection of the returned staplers: stapler 1: 17 pieces of staples were left in the cartridge in line correctly.Stapler 2: 11 pieces of staples were left in the cartridge not uniform.The left side of staple release area of the cartridge was turned up.The latch of the cartridge was unhooked.Stapler 3: 8 pieces of staples were left in the cartridge not uniform.The left side of the cartridge was turned up.Stapler 4: 16 pieces of staples were left in the cartridge not uniform.The one staple was stuck at the staple release area.The left side of the cartridge was turned up.2) reproducibility test before disassembling the returned staplers (staple release test): stapler 1: the remaining staples, 17 pieces were released but there was with some snap sound.Stapler 2: the remaining staples, 11 pieces were released in a bad shape.Forming failure was observed.Stapler 3: the second staple of the remaining staples, 8 pieces in the cartridge was released in a bad shape.Forming failure was observed.Stapler 4: reproducibility was not observed.3) disassembled components check of the returned stapler 2 and 3: no problem was found with the measured values of each component of the returned stapler 2 and 3.Left side groove of the ram was deformed.Both corners of anvil were worn.4) reproducibility test after reassembling with the new anvil, and reloaded 36 pieces of staples into the returned stapler 2 and 3: all the staples were released properly and stapling function worked without any problems.As the results of the investigation, no problem was found with the production record and measured values of each component of all the returned staplers.Unhooked latch and damaged components such as anvil and ram were observed with the returned stapler 2 and 3, and reproducibility was observed with these two staplers.However, when damaged components were replaced with hooked latch, stapling function worked properly.It is highly probable that an unexpected overload of pressure or usage was applied to the products during the application and some of the components were damaged causing the malfunction under an unexpected situation.Final conclusion: although reproducibility was observed with the returned stapler 2 and 3, it is highly probable that an unexpected overload of pressure or usage was applied to the products during application and some components were damaged causing the malfunction under an unexpected situation.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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