BoneScalpel BCM-GNRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841626100664), received between Sep 12, 2017 and Jul 28, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2020Infusion or Flow Problem; Infusion or Flow Problem

  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.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10332454 ↗
• MalfunctionJun 27, 2019Electrostatic Discharge; Electrostatic Discharge

  CUSTOMER STATED PROBLEM: "1ST AND 2ND HANDPIECES NOT WORKING - HAND PLACED ON TOP OF GENERATOR AND PULLED OUT THE HANDPIECE AND RECEIVED SHOCK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741811 ↗
• MalfunctionDec 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CUSTOMER STATED PROBLEM AS, "THIS MACHINE HAS BEEN IN HOSPITAL TO BE CHECKED BEFORE USING WITH PATIENTS. THEY FOUND OUT THAT THERE IS ELECTRICITY LEAK FROM THE MACHINE 5406UA ( THEY ACCEPT MAX 5000UA). WE ARE NOT ABLE TO USE THIS MACHINE WITH PATIENTS. THIS MACHINE HAS NOT BEEN USED ON THAT HOSPITAL WITH PATIENTS TREATMENTS. THERE HAS BEEN ONLY DEMONSTRATION FOR THE STAFF."

  Patient problems: No Patient Involvement

  MAUDE report 8186908 ↗
• InjurySep 12, 2017Electrical Shorting; Electrical Shorting

  THE REPORT IS FOR A PATIENT BURN. NO DEATH WAS REPORTED. THE DEGREE OF THE BURN WAS NOT REPORTED. NO INFORMATION WAS PROVIDED IF THE BURN CAUSED PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. NO INFORMATION WAS PROVIDED AS TO WHETHER MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. NO DELAY IN TREATMENT WAS REPORTED. PATIENT INFORMATION AND CLINICAL HISTORY WAS NOT PROVIDED. THE SURGICAL PROCEDURE PERFORMED WAS NOT PROVIDED. THE DATE OF THE EVENT WAS NOT REPORTED. THE DATE OF THE EVENT IS ESTIMATED FROM STATEMENTS MADE IN THE VERBATIM REPORT FROM THE CUSTOMER. THE REPORTER STATED A MALFUNCTION OCCURRED - AN ELECTRICAL SHORT WITHIN THE GENERATOR WAS REPORTED AS CAUSING THE ADVERSE EVENT OF A PATIENT BURN. THE VERBATIM REPORT FROM CUSTOMER (HOSPITAL CONTACT) IS AS FOLLOWS: SPOKE TO EQUIPMENT MANAGER ON 6/27/2017 RE: PROBLEM WITH CONSIGNED BS GENERATOR. HE SAID THE REPORT HE HAD GOTTEN WAS THAT THE GENERATOR SHORTED OUT AND HE SAID THERE WAS A PATIENT BURN. I ASKED HIM WHEN THIS HAPPENED AND HE SAID IT WAS APPROXIMATELY 3 WEEKS AGO AND THAT SOMEHOW THE INFO HAD NOT GOTTEN TO HIM UNTI

  Patient problems: Burn(s)

  MAUDE report 6857793 ↗