MAUDE Adverse Event Report: MISONIX NEXUS BONESCALPEL MICRO HOOK MIS; ULTRASONIC SURGICAL ASPIRATOR SYSTEM

Model Number 110-31-2210

Device Problem Output Problem (3005)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Additional information pending.

Event Description

Misonix sales representative states: "i was notified of this issue significantly after the case.Dr.(b)(6) said that on one of his patients he used the mis microhook shaver and where the black housing and silicone meet, caused a burn mark on the patient's skin.The patient has come to multiple follow up appointments and the burn does not seem to be healing at all.Dr.(b)(6) also said the stitches are not holding where the burn is.".

• Brand Name: NEXUS BONESCALPEL MICRO HOOK MIS
• Type of Device: ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Manufacturer (Section D): MISONIX; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735 ; 6319279123
• MDR Report Key: 12839509
• MDR Text Key: 281007540
• Report Number: 2435119-2021-00023
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00841626103047
• UDI-Public: 00841626103047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 110-31-2210
• Device Lot Number: 203078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• 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?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other