H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality was confirmed; the probe is giving a poor image.The site rite 8 was visually inspected upon receipt and was found to be in poor physical condition.The probe is giving a poor image due to an internal failure of the probe.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.H3 other text: evaluation findings are in section h11.
|