MAUDE Adverse Event Report: THERMO FISHER SCIENTIFIC (SHANGHAI) INSTRUMENTS CO. LTD MICROTOME; MICROTOME, ROTARY

Model Number HM355 S

Device Problems Patient-Device Incompatibility (2682); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 11/01/2021

Event Type  Injury  

Event Description

The histologist was cutting tissue blocks.The chuck on the microtome did not release the tissue block.The chuck jumped when the histologist.Attempted to manually release the tissue block.At that moment the chuck slammed down toward the blade, catching the: right hand of the histologist this action caused a laceration of the right middle finger and right thumb.The lacerations required 2-3 stitches on the right thumb and middle finger.

• Brand Name: MICROTOME
• Type of Device: MICROTOME, ROTARY
• Manufacturer (Section D): THERMO FISHER SCIENTIFIC (SHANGHAI) INSTRUMENTS CO. LTD
• MDR Report Key: 12813494
• MDR Text Key: 280845898
• Report Number: MW5105295
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HM355 S
• Device Catalogue Number: 905200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White