WickiMed 138505-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06970739450046), received between Jan 13, 2023 and Jan 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. 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.

• MalfunctionJan 13, 2023Material Integrity Problem; Material Integrity Problem

  VOLUNTARY DISTRIBUTOR REPORT THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 138505-10, TUNGSTEN MICRO NEEDLE 3CM, STRAIGHT, WAS BEING USED DURING A SPINE SURGERY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED DURING USE OF THIS PRODUCT, A MEDICAL ACCIDENT OCCURRED IN WHICH AN INSULATED TUBE FELL OFF AND ENTERED THE BODY. FORTUNATELY, THE INSULATING TUBE WAS SUCKED OUT AND REMAINED INSIDE THE BODY. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE TUBE WAS SUCKED OUT BY SUCTION AND WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TUNGSTEN MICRO NEEDLE AND THE SURGERY WAS EXTENDED FOR AN UNKNOWN AMOUNT OF SURGERY TIME. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS RECOVERING. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158920 ↗