MAUDE Adverse Event Report: AQUA JET ROUTINE I TAPED CASS NO/LID

Catalog Number 38440010

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

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.Returned cassette and metal lid were tested.The returned metal lid and cassette were tested during a standard eight (8) hour run in the leica peloris processor.The testing confirmed the lid detached from the cassette.The customer could not identify the exact lot number assigned to the returned cassette in question.Therefore three lot numbers were provided that the customer was able to confirm the cassette came from.A box of each of the three cassette lot numbers were returned from the customer for additional testing.All cassettes performed as intended and none detached from the lid in the leica peloris tissue processor.The single cassette was identified as an isolated event.If additional information becomes available a follow-up mdr will be submitted.This is mdr number 2 of 3 to cover the three potential lot numbers reported by the customer.This mdr is for lot number a24106910.

Event Description

On (b)(6) 2021 the customer experienced one (1) cassette of the aqua jet routine i taped cass no/lid (p/n38440010, lot a24106910) with a metal lid, which had opened during processing causing the entire lymph node to be lost.

• Brand Name: AQUA JET ROUTINE I TAPED CASS NO/LID
• Type of Device: AQUA JET ROUTINE I TAPED CASS NO/LID
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8156782000
• MDR Report Key: 12502106
• MDR Text Key: 272420576
• Report Number: 1419341-2021-00003
• Device Sequence Number: 1
• Product Code: IDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 38440010
• Device Lot Number: A24106910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2021
• 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