MAUDE Adverse Event Report: MISONIX INC ULTRASONIC OSTEOTOME SYSTEM

Model Number	E-BC06
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The legal agent reported an adverse event to misonix on (b)(6) 2020 for a lumbar discectomy in which "the water suddenly decreased, leading to a sudden rise in the temperature of the ultrasonic bone knife and scalding of the patient" for ultrasonic osteotome system p/n e-bc06.The device was not returned to misonix for a physical evaluation from the customer.The ifu contains the following warnings and cautions: warning 1.2: the bonescalpel system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.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 3.3: 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.Warning 7.2: do not operate pump with pump cover in raised position.Rollers might pinch loose clothing or fingers.Personal injuries may result.Cooling of the ultrasonic tip and irrigation at the treatment site will be inhibited.Warning 7.3: heat is being generated at the tip/tissue interface.A continuous, lateral sweeping motion is recommended for general bone/tissue removal in order to minimize contact duration with the ultrasonic tip and minimize the temperature increase.Caution 4.2: insufficient irrigation and high tip pressure (loading) under extended exposure, e.G.In tight cavities, are to be avoided in bonescalpel hard tissue removal.It is recommended to withdraw and re-insert the ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.Caution 4.3: 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 of the skull, when using the bonescalpel accessories.Caution 7.5: do not pinch the soft silicone tube when the latch is locked.Caution 7.7: prime the irrigation tubing prior to use.At all times ensure that the irrigant flows towards the handpiece when footswitch is depressed.If no irrigant is flowing, cease use until flow is restored.Caution 7.8: the system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.The investigation has been concluded.
Event or Problem Description
The legal agent reported an adverse event to misonix inc.On (b)(6) 2020 for a lumbar discectomy in which "the water suddenly decreased, leading to a sudden rise in tempreature of the ultrasonic bone knife and scalding the patient" for ultrasonic osteotome system p/n e-bc06.

• Brand Name: ULTRASONIC OSTEOTOME SYSTEM
• Common Device Name: ULTRASONIC OSTEOTOME SYSTEM
• Manufacturer (Section D): MISONIX INC; 1938 new highway; farmingdale NY 11735
• MDR Report Key: 10332454
• Report Number: 2435119-2020-00001
• Device Sequence Number: 3451277
• Product Code: LFL
• UDI-Device Identifier: 00841626100664
• UDI-Public: 00841626100664
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: E-BC06
• Device Lot Number: BC-0861-2014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1