MAUDE Adverse Event Report: LEICA BIOSYSTEMS IP BIOPSY CASSETTE II, TAPED, WHITE

Model Number N/A

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

Patient Problem Tissue Breakdown (2681)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

Device history review was completed.There were no deviations or non-conformances associated with this lot.Trending analysis reported no (0) other related occurrences of this issue for this product lot.Quality control testing was complete and passed.A retain sample analysis was completed.This is a isolated incident, there is no data to confirm manufacturing deviation.If additional information is received an additional follow up mdr will be submitted.

Event Description

On (b)(6) 2022 the customer experienced tissue loss while using the ip biopsy cassette ii, taped, white, p/n 38440500, lot 924510138 which opened easily during tissue processing.On (b)(6) 2022 leica biosystems became aware that the patient had to be re-biopsied for a diagnosis due to no additional tissue available.

Manufacturer Narrative

D3 was corrected to include the manufacturing address.H5 was corrected to include this is labeled for single use.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: IP BIOPSY CASSETTE II, TAPED, WHITE
• Type of Device: IP BIOPSY CASSETTE II, TAPED, WHITE
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us-12; richmond IL 60071
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 14635501
• MDR Text Key: 294851951
• Report Number: 1419341-2022-00003
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 38440500
• Device Lot Number: 924510138
• Was Device Available for Evaluation?: No
• 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: 09/02/2021
• 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