MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. TISSUE-TEK(R) CRYO3(R) FLEX, 115 V BASIC, MOHS; CRYO3 FLEX MOHS

Catalog Number 6209

Device Problem Misassembly by Users (3133)

Patient Problems Injury (2348); Skin Tears (2516)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

Microtome blades are extremely sharp and inherently dangerous.Inattention to the task at hand and failure to follow the procedure can cause a serious injury.The operating manual has a warning in section 1 to alert users to be careful when handling exposed blade.

Event Description

Sakura was notified on (b)(4) 2018, that user cut her finger and had to get stitches.User was having trouble placing a knife into the holder, says it was because of the excess frost buildup on the blade holder.When placing the blade she was not able to get it in the whole way.She was in a hurry, so she began cutting with a large portion of the blade exposed.During sectioning her hand slipped and her finger was cut.She had to go to the emergency room and get stitches the same day.

Manufacturer Narrative

In general, mohs industry users tend to leave the chamber window open for a longer period of time, allow more moisture to accumulate inside the chamber.As a precaution, the operational relative humidity specification in the operating manual and product specification was changed from 15~85% (non-condensing) to 15~50% (non-condensing) in order to prevent frost build up inside the cryo chamber.

• Brand Name: TISSUE-TEK(R) CRYO3(R) FLEX, 115 V BASIC, MOHS
• Type of Device: CRYO3 FLEX MOHS
• Manufacturer (Section D): SAKURA FINETEK USA, INC.; 1750 west 214th street; torrance CA 90501
• Manufacturer (Section G): SAKURA FINETEK USA, INC.; 1750 west 214th street; torrance CA 90501
• Manufacturer Contact: solmaz shaida ; 1750 west 214th street; torrance 90501 ; 3109727800
• MDR Report Key: 7262144
• MDR Text Key: 99770624
• Report Number: 2083544-2018-00003
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Technologist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Catalogue Number: 6209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other