IP ACTIVFLO BIOPSY III, ORANGE TISSUE CASSETTES
Received Jul 11, 2018 · Event occurred Jun 11, 2018
Report 1419341-2018-00003 · MDR key 7679701
Device
Generic name
Tissue Cassettes
Manufacturer
Leica Biosystems RichmondModel number
39LC-625-7Lot number
625-LID-7-171221-A Q14
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
54 YR
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
AS PER CUSTOMER CONTACT, ONE PATIENT ((B)(6 )YEAR OLD MALE) SPECIMEN (RECTUM POLYP) IN 1 LEICA ACTIVFLO BIOPSY III CASSETTE WAS LOADED ON A VIP PROCESSOR ON FRIDAY, (B)(6) 2018 TO COME OFF ON MONDAY, (B)(6) AT 5:30 AM. THE LID OF THE CASSETTE REPORTEDLY OPENED DURING PROCESSING AND THE SPECIMEN WAS LOST. TOTAL NUMBER OF CASSETTES LOADED IN THE RUN WAS 71. A SAMPLE OF THE CASSETTES WAS PROVIDED TO THE SALES REPRESENTATIVE BY THE CUSTOMER AND WAS SENT BACK TO THE MANUFACTURER FOR EVALUATION. ADDITIONALLY, PRODUCT OF THE SAME LOT REPORTED WAS PULLED FROM INVENTORY FOR TESTING BY QA HISTOTECHS TO ATTEMPT TO REPLICATE CUSTOMER COMPLAINT. ALL CASSETTES REMAINED CLOSED DURING PROCESSING. UPON THE RECEIPT OF PRODUCT RETURNED BY THE CUSTOMER, THE PRODUCT WAS SENT TO QA HISTOTECHS TO ATTEMPT TO REPLICATE CUSTOMER COMPLAINT. ALL CASSETTES REMAINED CLOSED. IN OPENING THE CASSETTES AFTER PROCESSING, THERE WAS THE EXPECTED AMOUNT OF RESISTANCE IN REMOVING THE LIDS. ALL CASSETTES WERE FOUND TO FUNCTION AS DESIGNED.
Description of Event or Problem
ON MONDAY, (B)(6), A SALES REPRESENTATIVE OF LEICA BIOSYSTEMS WAS NOTIFIED OF PATIENT TISSUE LOST BY THE CUSTOMER DUE TO THE CASSETTES REPORTEDLY OPENING DURING PROCESSING. PATIENT MUST UNDERGO ANOTHER BIOPSY DUE TO TISSUE LOSS.