n.a. 26183MD-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551393567), received between Jul 11, 2019 and Aug 31, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527683 ↗
• MalfunctionApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INTRAOPERATIVE USE OF THE SUPRA-LOOP, IT WAS DISCOVERED THAT THE COATING AT THE DISTAL END OF THE LOOP WAS DEFECTIVE. THE INSTRUMENT (LOOP) WAS REPLACED INTRAOPERATIVELY WITH ANOTHER IDENTICAL LOOP. THE SURGERY WAS ABLE TO CONTINUE. DISTAL END OF THE LOOP: COATING DETACHED NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886515 ↗
• InjuryNov 26, 2025Lack of Effect; Lack of Effect

  ACCORDING TO THE INFORMATION RECEIVED, POOR CUTTING FUNCTION, CUTTING FUNCTION WAS QUESTIONABLE, CURRENT FUNCTION WAS QUESTIONABLE. CERVIX WAS SEVERED PRIMARILY BY PULLING ON THE LOOP. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION, CUTTING FUNCTION WAS QUESTIONABLE, CURRENT FUNCTION WAS QUESTIONABLE. CERVIX WAS SEVERED PRIMARILY BY PULLING ON THE LOOP.HF SETTING: LASH PROGRAM. MAX 130 WATTS, SOFTCUT - SMOOTH CUTTING. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY WITH LESS THAN 15 MINS DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659237 ↗
• InjuryNov 26, 2025Lack of Effect; Lack of Effect

  ACCORDING TO THE INFORMATION RECEIVED, POOR CUTTING FUNCTION, CUTTING FUNCTION WAS QUESTIONABLE, CURRENT FUNCTION WAS QUESTIONABLE. CERVIX WAS SEVERED PRIMARILY BY PULLING ON THE LOOP. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION, CUTTING FUNCTION WAS QUESTIONABLE, CURRENT FUNCTION WAS QUESTIONABLE.CERVIX WAS SEVERED PRIMARILY BY PULLING ON THE LOOP.HF SETTING: LASH PROGRAM. MAX 130 WATTS, SOFTCUT - SMOOTH CUTTING. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY WITH LESS THAN 15 MINS DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659220 ↗
• MalfunctionApr 28, 2021Fracture; Fracture

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE SUPRALOOP BROKE DURING REMOVAL OF UTERUS AND CAUSED BLEEDING. PER THE NURSE THE BLEEDING VESSEL WAS CLIPPED TO OBTAIN HEMOSTASIS IN SURGERY, NO FURTHER TREATMENT REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11738350 ↗
• MalfunctionJul 16, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE SUPRALOOP BROKE AND THE COLON WAS NICKED. PER THE NURSE MANAGER, "THE PATIENT WAS HARMED BUT THE WOUND WAS REPAIRED IN SURGERY, NO FURTHER COMPLICATIONS NOTED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794079 ↗
• InjuryJul 11, 2019Defective Device

  SIGMOID COLON NICKED DURING SURGERY. SURGEON STATED THE "NICK" WAS A RESULT OF A DEFECTIVE PRODUCT (SUPER LOOP).

  Patient problems: Laceration(s)

  MAUDE report 8785856 ↗