J-PLASMA® BVX-270BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607151009458), received between Jul 24, 2018 and Dec 4, 2020 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (6 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IN (B)(6), IT WAS REPORTED DURING THE PROCEDURE A PART OF THE STAINLESS STEEL BLADE SNAPPED OFF CLOSE TO THE INSERTION SITE AND WENT UNNOTICED BY THE USER. THE PATIENT RETURNED TO THE CLINIC "A COUPLE DAYS LATER" WITH COMPLAINTS OF DISCOMFORT TO A SPECIFIC AREA OF THE LEFT THIGH WHICH VISUALLY DEMONSTRATED A "POINT" (RAISED LUMP). THE PIECE OF BLADE JUST UNDER THE SKIN AND WAS REMOVED VIA A SMALL INCISION WITHOUT REPORTED COMPLICATION. THERE WAS NO INFECTION AND NO FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10946013 ↗
• InjuryOct 8, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  PATIENT PRESENTED WITH THIRD DEGREE BURNS ON THE INTERIOR AND LATERAL THIGHS WITH NO POST INFECTION OR FAT NECROSIS. THE INVESTIGATION CONCLUDED THAT THE REPORTED ISSUE IS ASSOCIATED WITH POOR SURGICAL TECHNIQUE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 10647697 ↗
• InjuryJul 31, 2020Use of Device Problem; Use of Device Problem

  DURING CLINICAL USE IN (B)(6), AN UNEXPECTED STRESS FRACTURE OCCURRED ON THE SHAFT OF THE HANDPIECE RESULTING IN FRAGMENTATION. THE ISSUE WAS NOT RECOGNIZED BY THE USER AND RESULTED IN AN ADDITIONAL MEDICAL INTERVENTION TO REMOVE THE FRAGMENT FROM THE PATIENT. THE PATIENT RECOVERED WITH NO COMPLICATIONS.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 10351440 ↗
• MalfunctionJun 24, 2020Use of Device Problem; Use of Device Problem

  DURING CLINICAL USE, AN UNEXPECTED STRESS FRACTURE OCCURRED ON THE SHAFT OF THE HANDPIECE RESULTING IN FRAGMENTATION. THE ISSUE WAS RECOGNIZED BY THE USER AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THERE WAS NO INJURY TO THE PATIENT OR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191061 ↗
• MalfunctionApr 23, 2020Use of Device Problem; Use of Device Problem

  DURING CLINICAL USE, AN UNEXPECTED STRESS FRACTURE OCCURRED ON THE SHAFT OF THE HANDPIECE RESULTING IN FRAGMENTATION. THE ISSUE WAS RECOGNIZED BY THE USER AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THERE WAS NO INJURY TO THE PATIENT OR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989958 ↗
• InjuryApr 23, 2020Use of Device Problem; Use of Device Problem

  DURING CLINICAL USE, AN UNEXPECTED STRESS FRACTURE OCCURRED ON THE SHAFT OF THE HANDPIECE RESULTING IN FRAGMENTATION. THE ISSUE WAS NOT RECOGNIZED BY THE USER AND RESULTED IN AN ADDITIONAL MEDICAL INTERVENTION TO REMOVE THE FRAGMENT FROM THE PATIENT. THE PATIENT RECOVERED WITH NO ADDITIONAL COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 9989955 ↗
• MalfunctionMar 5, 2020Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE REPORTED COMPLAINT WAS THE HAND PIECE COULD ACTIVATE WITHOUT DEPRESSING THE TRIGGER.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 9793832 ↗
• MalfunctionFeb 20, 2020Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE REPORTED COMPLAINT WAS THE HAND PIECE COULD ACTIVATE WITHOUT DEPRESSING THE TRIGGER.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 9731761 ↗
• MalfunctionOct 25, 2019Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE REPORTED COMPLAINT WAS THE HAND PIECE STAYED ACTIVATED WHEN RELEASING THE TRIGGER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238447 ↗
• MalfunctionJul 18, 2019Blocked Connection; Connection Problem; Blocked Connection; Connection Problem

  AFTER 30 MINUTES OF USE, THE HAND PIECE WAS REMOVED FROM THE PATIENT AND ACTIVATED AGAINST METAL CAUSING A FLAME THAT BURNED THE TIP OF THE CANNULA.

  Patient problems: No Patient Involvement

  MAUDE report 8803553 ↗
• MalfunctionApr 24, 2019Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE REPORTED COMPLAINT WAS THE HAND PIECE COULD ACTIVATE WITHOUT DEPRESSING THE TRIGGER. TESTING OF THE DEVICE SHOWED IT TO BE WORKING AS INTENDED. THE REPORTED PROBLEM WAS NOT ABLE TO BE REPLICATED. THIS IS THE 3RD DEVICE OF 3 FROM THE REPORTED COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 8545747 ↗
• MalfunctionApr 24, 2019Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE REPORTED COMPLAINT WAS THE HAND PIECE COULD ACTIVATE WITHOUT DEPRESSING THE TRIGGER. TESTING OF THE DEVICE SHOWED IT TO BE WORKING AS INTENDED. THE REPORTED PROBLEM WAS NOT ABLE TO BE REPLICATED. THIS IS THE 2ND DEVICE OF 3 FROM THE REPORTED COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 8544791 ↗
• MalfunctionApr 24, 2019Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE REPORTED COMPLAINT WAS THE HAND PIECE COULD ACTIVATE WITHOUT DEPRESSING THE TRIGGER. TESTING OF THE DEVICE SHOWED IT TO BE WORKING AS INTENDED. THE REPORTED PROBLEM WAS NOT ABLE TO BE REPLICATED. THIS IS THE 1ST DEVICE OF 3 FROM THE REPORTED COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 8543926 ↗
• InjuryJul 24, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  COMPLAINT ALLEGED THAT THE PATIENT RECEIVED A BURN IN THE INCISION SITES RIGHT AND LEFT AREA OF THE ABDOMINAL AFTER A J-PLASMA PROCEDURE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7716424 ↗