IP BIOPSY CASSETTE II, TAPED, PINK
Received Apr 23, 2026 · Event occurred Mar 27, 2026
Report 1419341-2026-00007 · MDR key 24973940
Device
Generic name
Cassettes, Tissue
Manufacturer
Simport Scientifique Inc.Model number
IP BIOPSY CASSETTE II, TAPED, PINKCatalog number
38440501
Lot number
9132511120
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS AND REPORTED "...A CASSETTE LID BROKE AND TISSUE ESCAPED DURING PROCESSING AND WAS LOST." NO ADVERSE IMPACT TO ANY PATIENT HAS BEEN REPORTED TO THE MANUFACTURER.
Additional Manufacturer Narrative
THE CUSTOMER REPORTED IP BIOPSY CASSETTE II, TAPED, PINK, P/N 38440501, LOT 9132511120 CASSETTE LID BROKE, THE TISSUE ESCAPED DURING PROCESSING AND WAS LOST. THE PATIENT DID NOT HAVE TO BE RE-BIOPSIED FOR DIAGNOSIS. TRENDING ANALYSIS FROM (B)(6) 2025 TO (B)(6) 2026 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. THE PRODUCT HISTORY WAS REVIEWED AND DID NOT IDENTIFY INFORMATION IN THE MANUFACTURING RECORD FOR THIS PRODUCT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PROBLEM REPORTED IN THIS COMPLAINT. PRODUCT RETAINED WAS EXAMINED BY REPEATED OPENING AND CLOSING OF CASSETTE TO ASSESS FOR THE TAB BREAKING OFF. TAB BREAKING OFF WAS NOT ABLE TO BE REPLICATED. THE ROOT CAUSE FOR THE "CASSETTE LID BROKE AND TISSUE ESCAPED DURING PROCESSING AND WAS LOST" COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.