J-Plasma® APYX-330BPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607151050078), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Material Fragmentation; Use of Device Problem; Patient Device Interaction Problem; Material Fragmentation; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A PROCEDURE WITH RENUVION, A FRAGMENT OF THE BLADE FROM THE APYX MEDICAL DEVICE BROKE OFF INSIDE OF THE PATIENT. THIS EVENT OCCURED AS THE SURGEON DID NOT RETRACT THE BLADE PRIOR TO THE SUBDERMAL COAGULATION AS RECOMMENDED BY THE INSTRUCTION FOR USE. C-ARM (X-RAY) WAS USED TO LOCATE THE TIP. A FRAGMENT ABOUT A 1-2MM WAS FOUND OVER THE PATIENT'S LEFT SCAPULA AREA. THE SURGEON ATTEMPTED TO REMOVE THE FRAGMENT WITH VARIOUS TECHNIQUES BUT WAS NOT SUCCESSFUL. THE BROKEN TIP WAS UNABLE TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH NEW HANDPIECE. HOWEVER, THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12515256 ↗