MAUDE Adverse Event Report: RICHARD ALLAN SCIENTIFIC THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN

Model Number C-0250-GR

Device Problem Defective Device (2588)

Patient Problem Infiltration into Tissue (1931)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

Thermo scientific¿ tissue-loc¿ histoscreen¿ cassettes are used for handling small biopsies and fragile specimens.The unique design provides an inner chamber lined with a "see-through" mesh for easy identification of specimens.They eliminate the need for messy sponges or lens papers.Tissue-loc histoscreen cassettes are available in bulk packaging and in tubes intended for high throughput printing.The customer complained that the screen on the tissue-loc cassette was defective.This caused tissue to be lost during processing.

Event Description

The customer claimed that the screen on the lid of the tissue-loc cassette was defective.This caused tissue to be lost during processing of the tissue and the patient had to be rebiopsied.

• Brand Name: THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN
• Type of Device: THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN
• Manufacturer (Section D): RICHARD ALLAN SCIENTIFIC; 4481 campus drive; kalamazoo MI 49008
• Manufacturer Contact: bowerman ; 4488 campus drive; kalamazoo, MI 49008 ; 2695445625
• MDR Report Key: 7071353
• MDR Text Key: 94276862
• Report Number: 1831638-2017-00001
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C-0250-GR
• Device Catalogue Number: N/A
• Device Lot Number: 103710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• 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