The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken probe cover confirmed and appeared to be related to the use of the device.Two siterite probe cover kits were returned for investigation in opened packaging.This report addresses the second sample.The product label showed lot: redq0594.The probe cover was removed from the packaging.Evidence of use was observed as gel was present throughout the sample.The second bag was observed to have a large hole near the distal end.Microscopic observation of the holes in the first probe cover revealed them to be ¿c¿ shaped.The edges were rough and uneven.The second probe cover tear edges were also observed to be rough and uneven.The surrounding material showed evidence of plastic deformation.Based on the characteristics of the damage observed on both probe covers, the damage was likely caused during handling and use of the device.The product instructions for use (ifu) states, "caution: always snap the needle guide on to the probe hook.Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear.".
|