HS AMICA AMICA-PROBE (REF APK16200T19V5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033055147200), received between Mar 31, 2021 and Mar 31, 2021 — classified as 1 malfunction.

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 18, 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.

• MalfunctionMar 31, 2021Material Fragmentation; Material Fragmentation

  BELOW WE REPORT THE EVENT DESCRIPTION SHOWN ON THE UF REPORT NO (B)(4). PATIENT WAS UNDERGOING MICROWAVE ABLATION FOR LIVER HEPATOCELLULAR CARCINOMA WITH ANESTHESIA. MICROWAVE ANTENNA WAS INSPECTED AND CONNECTED TO GENERATOR AND CHECKED PER PROTOCOL PRIOR TO PLACING THE PROBE THROUGH THE SKIN INTO THE LIVER. ON SERIAL INTRA-PROCEDURAL IMAGING, IT WAS NOTED THAT THE TIP OF THE PROBE WAS MISALIGNED ON THE CT IMAGES. IT WAS DECIDED TO WITHDRAW THE ANTENNA TO INSPECT IT PRIOR TO PERFORMING MICROWAVE ABLATION OF THE TARGET TUMOR. THE PROBE WAS RETRACTED OUTSIDE OF THE SKIN ENTRY SITE. AT THAT POINT, IT WAS NOTED THAT AN 8 MM FRAGMENT FROM THE TIP OF THE PROBE HAS BROKEN OFF AND WAS RETAINED IN THE ABLATION TRACT. ON IMAGING, THE FRAGMENT APPEARS TO HAVE BEEN LODGED IN THE FASCIA. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE IT UNDER IMAGE GUIDANCE WITHOUT SUCCESS. THIS MICROWAVE PROBE (16G 20CM HS AMICA) HAS NOW BEEN PULLED OFF THE SHELF UNTIL THERE IS FURTHER INVESTIGATION OF THE INTEGRITY OF THE PROBES IN THIS LOT NUMBER (LOT #38984). TECHNIQUE: PATIENT WAS POSITIONED SUPINE ON THE CT TABLE. LIMITED SCAN THROUGH THE ABDOMEN DEMONSTRATED KNOWN LESIONS IN SEGMENT 4 AND 3. ATTENTION WAS THEN

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595529 ↗