ROBI 38610MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551328675), received between May 9, 2019 and Jun 30, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026No Display/Image

  IT WAS REPORTED THAT THE FORCEPS SCREW FELL INTO THE PATIENT. TO LOCATE THE SCREW, X-RAYS WERE TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 25668590 ↗
• InjuryJun 30, 2026No Display/Image

  IT WAS REPORTED THAT THE FORCEPS SCREW FELL INTO THE PATIENT. TO LOCATE THE SCREW, X-RAYS WERE TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 25668094 ↗
• MalfunctionJan 28, 2026Electrical /Electronic Property Problem; Temperature Problem

  IT WAS REPORTED THAT THE ITEM SPRAYS SPARKS DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202965 ↗
• MalfunctionDec 16, 2025Sparking; Sparking

  IT WAS REPORTED: "FORCEP SPARKING AND SMOKING. INSULATION HAS SEPARATED FROM THE COLLAR WHERE IT GOES INTO THE HANDLE ON ALL ITEMS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817623 ↗
• MalfunctionMay 14, 2025Thermal Decomposition of Device; Electrical /Electronic Property Problem; Overheating of Device; Thermal Decomposition of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT A ROBI CLAMP WAS BURNED DURING THE MEDICAL PROCEDURE. ACCORDING TO THE CUSTOMER, IT WAS USED IN A GYNECOLOGY PROCEDURE, WITH THE SAME BRAND OF AUTOCON HIGH FREQUENCY EQUIPMENT, USING THE RECOMMENDED ENERGY. THEY HAVE NOT IDENTIFIED WHAT COULD HAVE CAUSED THE FORCEPS TO BURN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020594 ↗
• MalfunctionMay 9, 2019Mechanical Problem; Firing Problem; Mechanical Problem; Firing Problem

  ALLEGEDLY, THERE WAS A SPARK FROM THE TIP OF THE INSTRUMENT IN THE PATIENT DURING A PROCEDURE. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597855 ↗