MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND LEICA BIOSYSTEMS; ACTIVFLO ROUTINE I-TAPED-YELLOW 1000

Model Number 39LC-500-9-L

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: LEICA BIOSYSTEMS
• Type of Device: ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND; 5205 us highway 12; richmond IL 60071
• Manufacturer (Section G): LEICABIOSYSTEMS RICHMOND; 5205 us highway 12; richmond IL 60071
• Manufacturer Contact: peter sparacio ; 5205 us highway 12; richmond, IL 60071 ; 8156782000
• MDR Report Key: 8299413
• MDR Text Key: 134866488
• Report Number: 1419341-2019-00001
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 39LC-500-9-L
• Device Lot Number: V20180721
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other