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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MISONIX INC BONESCALPEL, MICRO HOOK STANDARD SHAVER; ULTRASONIC SURGICAL ASPIRATOR
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MISONIX INC BONESCALPEL, MICRO HOOK STANDARD SHAVER; ULTRASONIC SURGICAL ASPIRATOR Back to Search Results
Model Number MXB-S1
Device Problem Use of Device Problem (1670)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Event Description
On oct 12, ortho coordinator, (b)(4), reported (to misonix sales representative) that dr.(b)(6) used one of our shavers.He apparently took the sheath off and leaned the shaver on the inside of the body cavity causing thermal burns at the incision site.
 
Manufacturer Narrative
Misonix received a verbal report of a patient injury on 10/12/2021.The reporter, a healthcare professional at (b)(6) medical center, reported that the surgeon used one of our shavers and "apparently took the sheath off and leaned the shaver on the inside of the body cavity causing thermal burns at the incision site." the following products were returned to misonix by the reporter: misonix bonescalpel microhook, standard shaver, part no.Mxb-s1, lot no.Not reported.Misonix bonescalpel handpiece, part no.Bcm-hp, serial no.(b)(4).Misonix ultrasonic surgical aspiration system/generator, part no.Bcm-gn, serial no.(b)(4).Misonix bonescalpel footswitch, part no.Bcm-fs, serial no.(b)(4).An evaluation was conducted of the returned products.A visual examination of the microhook standard shaver did not find any physical abnormalities.Results of function tests conducted in accordance with misonix procedures on the handpiece, generator, and footswitch were within specifications.The report stated that surgeon removed the sheath (the probe cover) during surgery and leaned the shaver on the inside of the body cavity during surgery.Conducting ultrasonic surgery with the sheath removed, and leaning the shaver on the inside of the body cavity during surgery, is inconsistent with the misonix bonescalpel instruction for use manual, part no.Bcm-um, revision u.Warning 4.1 states: contact to vibrating elements like extensions and ultrasonic tips 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.Misonix concludes that the returned products were within specifications.Misonix also concludes that the thermal burns at the incision were due to the sheath being removed from the probe during surgery and probe being leaned on the patient tissue at the incision during surgery, inconsistent with warning 4.1 of the bonescalpel ifu, part no.Bcm-um rev u.
 
Manufacturer Narrative
Misonix received a verbal report of a patient injury on (b)(6) 2021.The reporter, a healthcare professional at (b)(6) medical center, reported that the surgeon used one of our shavers and "apparently took the sheath off and leaned the shaver on the inside of the body cavity causing thermal burns at the incision site." the following products were returned to misonix by the reporter: misonix bonescalpel microhook, standard shaver, part no.Mxb-s1, lot no.Not reported.Misonix bonescalpel handpiece, part no.Bcm-hp, serial no.(b)(4).Misonix ultrasonic surgical aspiration system/generator, part no.Bcm-gn, serial no.(b)(4).Misonix bonescalpel footswitch, part no.Bcm-fs, serial no.(b)(4).An evaluation was conducted of the returned products.A visual examination of the microhook standard shaver did not find any physical abnormalities.Results of function tests conducted in accordance with misonix procedures on the handpiece, generator, and footswitch were within specifications.The report stated that surgeon removed the sheath (the probe cover) during surgery and leaned the shaver on the inside of the body cavity during surgery.Conducting ultrasonic surgery with the sheath removed, and leaning the shaver on the inside of the body cavity during surgery, is inconsistent with the misonix bonescalpel instruction for use manual, part no.Bcm-um, revision u.Warning 4.1 states: contact to vibrating elements like extensions and ultrasonic tips 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.Misonix concludes that the returned products were within specifications.Misonix also concludes that the thermal burns at the incision were due to the sheath being removed from the probe during surgery and probe being leaned on the patient tissue at the incision during surgery, inconsistent with warning 4.1 of the bonescalpel ifu, part no.Bcm-um rev u.
 
Event Description
On oct 12, ortho coordinator, (b)(4), reported (to misonix sales representative) that dr.(b)(6) used one of our shavers.He apparently took the sheath off and leaned the shaver on the inside of the body cavity causing thermal burns at the incision site.
 
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Brand Name
BONESCALPEL, MICRO HOOK STANDARD SHAVER
Type of Device
ULTRASONIC SURGICAL ASPIRATOR
Manufacturer (Section D)
MISONIX INC
1938 new highway
farmingdale NY 11735
Manufacturer (Section G)
MISONIX, INC
1938 new hwy
farmingdale NY 11735
Manufacturer Contact
john salerno
1938 new hwy
farmingdale, NY 11735
6319279123
MDR Report Key12807367
MDR Text Key285153839
Report Number2435119-2021-00022
Device Sequence Number1
Product Code LFL
UDI-Device Identifier00841626101210
UDI-Public00841626101210
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMXB-S1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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