n.a. 26183MC-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04048551393086), received between Aug 29, 2019 and Oct 15, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Break; Mechanical Problem; Excessive Heating; Break; Mechanical Problem; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2024, THE SUPRALOOP BROKE CAUSING INJURY TO THE OVARY AND BOWEL DURING CAUTERY AROUND THE UTERUS. THE SUPRALOOP WAS REMOVED AND A NEW SUPRALOOP WAS USED WITHOUT FURTHER ISSUES. APPROXIMATELY ONE HOUR WAS ADDED TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Bowel Burn; Burn(s)

  MAUDE report 20458045 ↗
• InjuryOct 15, 2024Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2024, THE SUPRALOOP BROKE CAUSING INJURY TO THE OVARY AND BOWEL DURING CAUTERY AROUND THE UTERUS. THE SUPRALOOP WAS REMOVED AND A NEW SUPRALOOP WAS USED WITHOUT FURTHER ISSUES. APPROXIMATELY ONE HOUR WAS ADDED TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Bowel Burn; Burn(s)

  MAUDE report 20457840 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT THE UNIT BROKE DURING CASE. WHILE SEPARATING THE UTERUS FROM THE CERVIX, THE LOOP BROKE. THERE WAS NO PATIENT IMPACT, AND THE DOCTOR WAS ABLE TO COMPLETE THE CASE WITH ANOTHER LOOP FROM THE SAME BOX. LOT IS 37KA9619. IT BROKE RIGHT AT THE DISTAL END OF THE LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397536 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT THE UNIT BROKE DURING CASE. WHILE SEPARATING THE UTERUS FROM THE CERVIX, THE LOOP BROKE. THERE WAS NO PATIENT IMPACT, AND THE DOCTOR WAS ABLE TO COMPLETE THE CASE WITH ANOTHER LOOP FROM THE SAME BOX. LOT IS 37JA97975, WHICH HAPPENED TO BE PART OF THE LAST RMA 200041212 THAT WAS REPLACING OTHER LOOPS. CUSTOMER WILL BE CHECKING TO SEE IF THEY HAVE ANY MORE OF THESE LOT CODE LOOPS ON THE SHELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385574 ↗
• MalfunctionJun 9, 2022Break; Material Separation; Break; Material Separation

  DURING A LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY WITH BSO, THE LOOP SNAPPED RATHER THAN CUTTING WHEN CAUTERY PEDAL WAS DEPLOYED. THE SURGEON COMPLETED THE CASE WITH ANOTHER SMALL LOOP, WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643315 ↗
• MalfunctionMay 25, 2022Break; Material Separation; Break; Material Separation

  DURING A LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY, THE LOOP BROKE. THE SURGEON COMPLETED THE CASE WITH ANOTHER LOOP, WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495485 ↗
• MalfunctionMay 19, 2022Break; Material Separation; Break; Material Separation

  DURING A LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY, THE LOOP BROKE. THE SURGEON COMPLETED THE CASE WITH ANOTHER LOOP, WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434662 ↗
• MalfunctionSep 26, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE METAL SNARE CAME LOOSE IN THE ABDOMEN AND WAS RETRIEVED WITH NO HARM TO THE PATIENT. THEY USED AN ADDITIONAL LOOP TO COMPLETE THE CASE SUCCESSFULLY WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124700 ↗
• MalfunctionSep 26, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE METAL SNARE CAME LOOSE IN THE ABDOMEN AND WAS RETRIEVED WITH NO HARM TO THE PATIENT. THEY USED AN ADDITIONAL LOOP TO COMPLETE THE CASE SUCCESSFULLY WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124486 ↗
• MalfunctionSep 11, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE LOOP BROKE PRIOR TO ENERGY BEING APPLIED AND THE METAL SNARE CAME LOOSE IN THE ABDOMEN AND WAS RETRIEVED WITH NO HARM TO THE PATIENT. THEY USED A SECOND LOOP TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8995235 ↗
• MalfunctionAug 29, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE PLASTIC LOOP BROKE AND THE METAL SNARE CAME LOOSE IN THE ABDOMEN AND WAS RETRIEVED WITH NO HARM TO THE PATIENT. THEY USED A SECOND LOOP TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947242 ↗
• MalfunctionAug 29, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE PLASTIC LOOP BROKE AND THE METAL SNARE CAME LOOSE IN THE ABDOMEN AND WAS RETRIEVED WITH NO HARM TO THE PATIENT. THEY USED A SECOND LOOP TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947220 ↗