MAUDE Adverse Event Report: LEICA BIOSYSTEMS IP ROUTINE VI TAPED, GREEN 1000

Catalog Number 39LC-550-4-L

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

A device history review was completed.There were no deviations or non-conformances associated with this lot.Quality control testing was complete and passed.The product poses a bio-hazard concern to have it returned for further testing by the manufacturer due to the exposure of tissue, therefore additional testing on the customer's slide cannot be completed.Retains are available and additional testing will be completed.Additional information will be submitted in a follow-up mdr.

Event Description

On (b)(6) 2021 the customer experienced one (1) cassette of the ip routine vi taped, green 1000 (p/n 39lc-550-4-l, lot 201911035), which had opened during processing causing tissue loss that required re-biopsy of the patient.

Manufacturer Narrative

A retain sample analysis was completed.The retain cassettes are of normal appearance and the lids all snapped and remained closed.The lids did not open or snap closed without the application of force, as expected.All the cassettes were ran on the leica peloris tissue processor.Upon completion of tissue processing, the cassettes were found to have remained closed and there were no cracks or disturbances to the plastic.All the cassettes demonstrated an audible snap when opened, indicating the closure was not damaged during processing.The bottom part of the lids were all attached to the base of the cassettes.The reported issue of the ip routine vi taped, green 1000, p/n 39lc-550-4-l, lot 201911035 opening causing tissue loss was not confirmed.If additional information is received an additional follow up mdr will be submitted.

Manufacturer Narrative

D3 was corrected to include the manufacturing address.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: IP ROUTINE VI TAPED, GREEN 1000
• Type of Device: IP ROUTINE VI TAPED, GREEN 1000
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us-12; richmond IL 60071
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8156782000
• MDR Report Key: 11925256
• MDR Text Key: 253966077
• Report Number: 1419341-2021-00001
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39LC-550-4-L
• Device Lot Number: 201911035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR