Coblation SDC01-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470006162), received between Jul 12, 2020 and Sep 20, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSIDE THE PATIENT, THE TIP OF THE WAND BROKE. SURGEON CONFIRMED THERE WERE NO BROKEN PIECES LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502254 ↗
• InjurySep 16, 2021Break; Break

  IT WAS REPORTED THAT DURING A CERVICAL NEUCLOPLASTY, THE TIP OF THE WAND WAS BROKEN. THERE WAS NO BROKEN TIP LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484421 ↗
• InjuryJul 12, 2020Break; Break

  IT WAS REPORTED THAT DURING A COLDPLASMA NEOCLOPLASTY OF CIV-CV, CVI-CVII, CVII-THI DISCS THE PERC DC SPINE TIP OF THE WAND HAS BROKEN OFF IT REMAINS INSIDE THE PATIENT VERTEBRAL BODY IN THE CIV-CV SEGMENT LEVEL. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. IN THE POSTOPERATIVE PERIOD, THE EXISTING NEUROLOGICAL DEFICIT REGRESSED SIGNIFICANTLY, THE VERTEBROGENOUS PAIN SYNDROME AND PARAVERTEBRAL MUSCLE TENSION PERSIST. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Intraoperative Pain

  MAUDE report 10262205 ↗