MAUDE Adverse Event Report: LEICA BIOSYSTEMS WHITE X-TRA SLIDES CASE

Catalog Number 3800200

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Tissue Damage (2104); Test Result (2695)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

Issue is currently being investigated.Additional information or investigation results will be submitted pending investigation completion.

Event Description

On (b)(6) 2020, the customer reported tissue loss that was cut at 4-5 microns that required re-biopsy of the patient.The tissue loss was found during staining with immunohistochemistry on a bond instrument.Re-biopsy of the patient was necessary for diagnosis.

Manufacturer Narrative

A device history review was completed.There was no deviations or non-conformnacess associated with this lot.Quality control testing was complete and passed.Product was discarded by the customer, therefore, additional testing on the slide cannot be completed.A retain sample analysis was completed.There were 30 randomly selected slides tested.All 30 slides had the tissue remain intact.The issue of tissue not adherising to the white x-tra slides case, p/n 3800200, lot 032620 was not confirmed.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: WHITE X-TRA SLIDES CASE
• Type of Device: WHITE X-TRA SLIDES CASE
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us-12; richmond, il
• MDR Report Key: 10374253
• MDR Text Key: 202009864
• Report Number: 1419341-2020-00001
• Device Sequence Number: 1
• Product Code: KES
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Catalogue Number: 3800200
• Device Lot Number: 032620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other