MAUDE Adverse Event Report: MISONIX, INC. BONESCALPEL; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number MXB-T

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

The tubing leaked when spiked.

• Brand Name: BONESCALPEL
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): MISONIX, INC.; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 11862236
• MDR Text Key: 251906242
• Report Number: 11862236
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2021

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 Operator: Health Professional
• Device Catalogue Number: MXB-T
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1