MAUDE Adverse Event Report: LEICA BIOSYSTEMS ORANGE PRELOAD II TAPED MICROBPSY (800/C)

Catalog Number 3802777T

Device Problem Insufficient Information (3190)

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

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, the customer reported 3 millimeter dermatology specimens loss that required re-biopsy of the patient.The tissue loss was found after tissue embedding.Re-biopsy of the patient was necessary for diagnosis.

Manufacturer Narrative

The dhr for part number 3802777t lot 112019 was reviewed.All quality control criteria indicated passing results and all other release criteria were met.A retain sample is not available for analysis.Product was discarded by the customer, therefore, additional testing on the cassette cannot be completed.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: ORANGE PRELOAD II TAPED MICROBPSY (800/C)
• Type of Device: ORANGE PRELOAD II TAPED MICROBPSY (800/C)
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us-12; richmond, il
• MDR Report Key: 10447753
• MDR Text Key: 204186317
• Report Number: 1419341-2020-00002
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 3802777T
• Device Lot Number: 112019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other