MAUDE Adverse Event Report: SAKURA FINETEK USA, INC. ACCU-CUT(R) SRM300(TM) 300 LT MANUAL MICROTOME (NON-RETRACT)

Catalog Number 1300N

Device Problem Device Handling Problem (3265)

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

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

Microtome blades are extremely sharp and inherently dangerous.Inattention to the task at hand and failure to utilize safety devices can cause a serious injury.The srm300 lt instrument is equipped with the hand wheel lock, brake, brake lock indicator (and red light), and the red colored blade guard as a safety device to protect the user from accidental exposure to the blade edge and injury when used properly.The instrument did not malfunction or cause this injury; it functioned as intended according to the specifications and is safe to use.

Event Description

Sfa was informed of a user finger cut injury on (b)(6) 2019.The lab technician was trimming a tissue block when she cut herself.She was not using the blade guard at the time because she could not see the tissue being cut.She said she was trimming and her hand got too close and was subsequently cut.She needed stitches, and according to the doctor her finger would be healed within one to two weeks.

• Brand Name: ACCU-CUT(R) SRM300(TM) 300 LT MANUAL MICROTOME (NON-RETRACT)
• Type of Device: SRM300
• 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: 8819508
• MDR Text Key: 152023549
• Report Number: 2083544-2019-00003
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1300N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other