Alleged failure: failed insulation.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.Although the product passed the insulscan, the failure identified in the investigation is consistent with the complaint record because there were dents and scratches on the insulation.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacture date is not known.(b)(4).
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