MAUDE Adverse Event Report: LEICA BIOSYSTEMS LEICA BIOSYSTEMS; GREEN JET BIOPSY II TAPED CASSETTE WITH LID, PRODUCT CODE: IDZ, PRODUCT CODE: ID

Model Number 38440502

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

Patient Problem Injury (2348)

Event Date 03/18/2019

Event Type  Injury  

Event Description

The customer reported the green jet biopsy ii taped cassette with lid opening during processing which caused one tissue sample to be lost which required additional biopsy.The customer reported two lot numbers (lot numbers a225899933 and a16289595) in their stock but was unable to determine which lot number experienced tissue loss.The lost biopsy was less than 5mm of skin tissue.Trending for on this issue was performed from the date january 1, 2018 to april 24, 2019 and no other issues were noted.Additional follow up was made to the customer to obtain product return for further investigation.No product was returned.No further investigation is available at this time.Report 1 of 2 as two lot numbers have been reported.1419341-2019-00003 is for lot numbers a16289595.

Event Description

The customer reported the green jet biopsy ii taped cassette with lid opening during processing which caused one tissue sample to be lost which required additional biopsy.The customer reported two lot numbers (a22589993 and a16289595) in their stock but was unable to determine which lot number experienced tissue loss.The lost biopsy was less than 5mm of skin tissue.Trending for on this issue was performed from the date (b)(6) 2018 to (b)(6) 2019 and no other issues were noted.Additional follow up was made to the customer to obtain product return for further investigation.No product was returned.No further investigation is available at this time.Report 2 of 2 as two lot numbers have been reported.14119341-2019-00003 is for lot numbers a16289595.

• Brand Name: LEICA BIOSYSTEMS
• Type of Device: GREEN JET BIOPSY II TAPED CASSETTE WITH LID, PRODUCT CODE: IDZ, PRODUCT CODE: ID
• Manufacturer (Section D): LEICA BIOSYSTEMS; 5205 us highway 12; richmond, il IL 60071
• MDR Report Key: 8685250
• MDR Text Key: 147571494
• Report Number: 1419341-2019-00003
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 38440502
• Device Lot Number: A16289595
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other