MAUDE Adverse Event Report: LEICA BIOSYSTEMS IP ACTIVFLO BIOPSY III, TAPED BLUE

Catalog Number 39LC-625-2-L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/20/2020

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.Product was discarded by the customer, therefore, additional testing on the slide cannot be completed.No retains or current inventory was available, therefore, additional testing could not be completed.If additional information is obtained a follow up mdr will be submitted.

Event Description

On (b)(6) 2020 the customer reported one cassette of the ip activflo biopsy iii, taped blue (39lc-625-2-l) lot v20190413-3 which had opened during processing causing tissue loss that required re-biopsy of the patient.

• Brand Name: IP ACTIVFLO BIOPSY III, TAPED BLUE
• Type of Device: IP ACTIVFLO BIOPSY III, TAPED BLUE
• 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: 10550320
• MDR Text Key: 207496854
• Report Number: 1419341-2020-00003
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA#S-P#NA
• 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
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2020
• Device Catalogue Number: 39LC-625-2-L
• Device Lot Number: V20190413-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No
• 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