MAUDE Adverse Event Report: MISONIX MISONIX BONESCALPEL WITH BONESHAVER MICRO HOOK; INSTRUMENT ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH ACCESSORY SHAVER

Model Number MXB-S1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

The report indicated that the misonix bonescalpel with the microhook shaver mxb-s1 was being used on mandible during surgery.Silicon insulated portion of the tip rested on the lip for an extended period of time.Lip tissue incurred burn regarding intervention from surgeon.The medical condition and surgical procedure was for ameloblastoma of the mandible.The specific intervention required was not reported.Misonix labeling clearly warns against having the silicon portion of the tip rest against tissue for an extended period of time.Specifically, the instructions for use for the bonescalpel provide the following warnings: warning 3.1 tip and irrigant temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used.For hard tissue removal , set the irrigation flowrate to a setting no less than the comparable vibration setting.For example, if the vibration setting is 7, a minimum flow setting of 70% should be used.Additional external irrigation, e.G.By administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.Warning 3.2 tissue necrosis may result if tip is not moved relative to tissue.A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up.When lateral motion is not possible withdraw and re-insert tip frequently.Warning 4.1 contact to vibrating elements like extension and ultrasonic tip may cause burns and should be avoided by all means.The handpiece should only be held at the black housing area.An optional, protective silicone sleeve, included with certain tips, reduces the risk of thermal damage but does not eliminate it.Contact with the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure.Pressure and extended exposure can still result in excessive frictional heat and cause burns.The device history record was reviewed for the microhook shaver mxb-s1 lot # 456470.All acceptance criteria were in conformance to specifications prior to the release of the lot.Trend analysis of complaints received on this accessory lot and this accessory for a period of 1 year from november 2014 to november 2015 does not indicate a trend for this event.

Event Description

Misonix boneshaver microhook was being used on mandible during surgery.Silicon insulated portion of tip rested on lip for extended period of time.Lip tissue incurred burn regarding intervention from surgeon.Surgery was for ameloblastoma of mandible.

• Brand Name: MISONIX BONESCALPEL WITH BONESHAVER MICRO HOOK
• Type of Device: INSTRUMENT ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH ACCESSORY SHAVER
• Manufacturer (Section D): MISONIX; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735 ; 6319279123
• MDR Report Key: 5266276
• MDR Text Key: 32663836
• Report Number: 2435119-2015-00004
• Device Sequence Number: 1
• Product Code: LFL
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MXB-S1
• Device Catalogue Number: MXB-S1
• Device Lot Number: 456740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 95