ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
Received Jun 25, 2025 · Event occurred May 31, 2025
Report 1419341-2025-00030 · MDR key 22333395
Device
Generic name
Cassettes, Tissue
Manufacturer
Leica Biosystems Richmond Inc.Model number
ACTIVFLO ROUTINE I-TAPED-YELLOW 1000Catalog number
39LC-500-9-L
Lot number
20240716
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED ACTIVFLO ROUTINE I-TAPED-YELLOW 1000, P/N: 39LC-500-9-L, LOT: 20240716 WAS POPPING OPEN. THE SMALL PLASTIC LOCKING PIECES ON THE FRONT OF THE CASSETTE ARE WEAKER THAN USUAL AND HAVE BEEN BREAKING OR NOT STRONG ENOUGH TO LOCK PROPERLY. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 13 JUN 2024 TO 13 JUN 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY ANY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MDR WILL BE SUBMITTED.
Description of Event or Problem
ON 31 MAY 2025, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION: "THE PA'S HAVE BEEN HAVING ISSUES WITH THE YELLOW CASSETTES "POPPING" BACK OPEN. SEEMS LIKE THE SMALL PLASTIC LOCKING PIECES ON THE FRONT OF THE CASSETTE ARE WEAKER THAN USUAL AND HAVE BEEN BREAKING OR NOT STRONG ENOUGH TO LOCK PROPERLY." ON (B)(6) 2025, THE CUSTOMER ADVISED "THERE WAS NO LOSS OF TISSUE. THE ISSUE WAS NOTICED AT GROSSING. THE LIDS WOULD KEEP POPPING BACK OPEN, SO THEY¿D PRINT NEW CASSETTES UNTIL THEY GOT SOME THAT STAYED CLOSE. IT ONLY WAS AN ISSUE AT GROSSING. NO RE BIOPSY NEEDED. IT WAS ALL TYPES OF OUR RUSH CASES: BREAST, LUNG, KIDNEY, COLON ETC." NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.
Additional Manufacturer Narrative
THE AWARENESS DATE FOR SUBMISSION 1419341-2025-00030 WAS INCORRECTLY ENTERED IN SECTION G3/4. THE CORRECT DATE WAS 30 MAY 2025.
Additional Manufacturer Narrative
MANUFACTURER TESTING OF RETAIN SAMPLES WAS UNABLE TO REPLICATE THE "YELLOW CASSETTES "POPPING" BACK OPEN" REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE "YELLOW CASSETTES "POPPING" BACK OPEN" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.