MAUDE Adverse Event Report: MISONIX INC BONESCALPEL IRRIGATION TUBESET; ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Model Number MXB-T

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

A serious injury to the patient or user was not reported.Medical intervention required to preclude serious injury was not reported.Delay in treatment was not reported.The bonescalpel® instructions for use manual includes the following cautions on tubesets: caution 7.4: do not place the soft silicon tube behind or in front of the rollers.Caution 7.5: do not pinch the soft silicon tube when the latch is locked.These cautions are to prevent damage to the soft silicon tube.

Event Description

On may 26, 2021, misonix received medwatch report number (b)(4) filed by (b)(6) medical center of a non-conforming irrigation tubeset (mxb-t).(b)(6) of (b)(6) medical center, (b)(6), reported the tubing leaked when spiked during a procedure on (b)(6) 2021.The irrigation tubeset was not used on the patient and replaced with a new one.

• Brand Name: BONESCALPEL IRRIGATION TUBESET
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11793
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735
• MDR Report Key: 12071333
• MDR Text Key: 277769208
• Report Number: 2435119-2021-00012
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00841626101258
• UDI-Public: 00841626101258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/25/2021

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 Model Number: MXB-T
• Device Lot Number: D192703A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3800750000-2021-8002
• Patient Sequence Number: 1
• Patient Outcome(s): Other