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, scratches, and a gap on the insulation.The device manufacture date is not known.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.Gtin: (b)(4).
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