Complaint data was reviewed from january 1st, 2017 to january 29th, 2019 and no other complaints were identified for this product lot that reported an issue with the product opening in processing.Five total products and eleven total lots were originally reported by the customer.Additional information was requested from the customer on the one product and lot that had irretrievable tissue loss.Product code 39lc-500-9-l, lot v20180721 was confirmed to have had irretrievable tissue loss by the customer.The product lot reported was not available in inventory for review by leica biosystems qa histotechs.Upon review with the sales team in contact with the customer, it was reported that the customer uses the same cassette multiple times.The product is labelled as a single use product only and the ifu states that the product lids should be discarded after one-time use.The customer used the product outside of intended use.No further investigation is required at this time.
|
The customer was processing two tissue biopsies with the product, code 39lc-500-9-l, and two tissue biopsies were lost.One biopsy, a skin inclusion approximately 1 cm in size, was divided into two blocks and was diagnosed using the second block.The second was a single biopsy of a bone marrow tissue sample and the patient had been recalled to re-make the biopsy.The incident was reported to leica biosystems on (b)(6) 2018.The complaint record was created (b)(6) 2018 stating that a risk of tissue loss was present.Additional information on potential loss of tissue was requested (b)(6) 2018.Confirmation of tissue loss was not provided to the complaint handling team until 21january, 2019.
|