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

Model Number	MXB-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11793
• MDR Report Key: 12071333
• Report Number: 2435119-2021-00012
• Device Sequence Number: 4188216
• Product Code: LFL
• UDI-Device Identifier: 00841626101258
• UDI-Public: 00841626101258
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K070313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: MXB-T
• Device Lot Number: D192703A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3800750000-2021-8002
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other