OMNI OMNI-S-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15420045515529), received between Oct 22, 2024 and Sep 24, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890372 ↗
• MalfunctionSep 10, 2026Entrapment of Device; Material Fragmentation; Defective Device; Material Integrity Problem

  As soon as it was put threw the sheath it came out the other end one of the blades shredded in a few pieces. We then removed the scissors, yet unfortunately there was metal and metal shavings left inside the patient from the defective scissors. Dr. was able to remove the shavings by opening up a Lite shaver. Then sending whole specimen to the lab for diagnostic assessment.

  Patient problems: Foreign Body In Patient

  MAUDE report 50713484 ↗
• InjuryMar 4, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST THE PROCEDURE ON (B)(6) 2026, THE PART OF THE JAWS BROKE INSIDE THE PATIENT ON THE TWO OMNISCOPE SCISSORS DEVICES USED DURING THE PROCEDURE. A SEPARATE DEVICE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN X-RAY WAS PERFORMED, AND THE JAWS WERE ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENT IS DOING WELL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24513170 ↗
• InjuryMar 4, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST THE PROCEDURE ON (B)(6) 2026, THE PART OF THE JAWS BROKE INSIDE THE PATIENT ON THE TWO OMNISCOPE SCISSORS DEVICES USED DURING THE PROCEDURE. A SEPARATE DEVICE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN X-RAY WAS PERFORMED, AND THE JAWS WERE ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENT IS DOING WELL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24507756 ↗
• MalfunctionNov 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN USED THE MYOSURE LITE DEVICE TO RESECT SOME POLYPOID TISSUE AND THE OMNI SCISSORS TO HELP TAKE DOWN SOME SCARRING IN THE PATIENT'S UTERUS. WHEN THE PHYSICIAN WENT BACK IN TO TAKE FINAL PICTURES, A LONG STRAND OF METAL IN THE PATIENT'S CAVITY WAS NOTED. THE PHYSICIAN REMOVED THE SHAVINGS USING THE GRASPERS. THERE WAS NO HARM REPORTED. AN X RAY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23569788 ↗
• MalfunctionJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OMNI PROCEDURE ON (B)(6) 2025, THE PHYSICIAN OBSERVED THAT THERE WERE METAL SHAVINGS OBSERVED IN THE PATIENT DURING THE PROCEDURE. PHYSICIAN USED A MYOSURE REACH TO OBTAIN ALL SHAVINGS. THERE WAS NO INJURY REPORTED AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. ON A FOLLOW UP IT WAS REPORTED THAT THE PHYSICIAN HAD USED A MYOSURE REACH PRIOR TO USING THE SCISSORS, THE PROCEDURE PERFORMED WAS THE REMOVAL OF ADHESIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22323009 ↗
• MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) AND DURING THE PROCEDURE WAS USED A SET OF OMNI SCISSORS WITH A MYOSURE SCOPE PRIOR TO A MYOSURE PROCEDURE. WHEN THE DOCTOR REMOVED THE SCISSORS FROM THE SCOPE TO INTRODUCE THE MYOSURE DEVICE, THE DOCTOR NOTICED WHAT LOOKED LIKE METAL SHAVINGS IN THE CAVITY. THE DOCTOR INSERTED THE MYOSURE DEVICE INTO THE CAVITY AND REMOVED THE SHAVINGS FROM THE CAVITY PRIOR TO RESECTING ANY TISSUE. THE DOCTOR USED A SECOND SET OF SCISSORS TO COMPLETE THE PROCEDURE AFTER THE MYOSURE PORTION WAS COMPLETED. THE SCOPE AND SCISSORS WERE INSPECTED POST-PROCEDURE AND THERE DID NOT APPEAR TO BE ANY DAMAGE FROM WHAT THEY COULD TELL. THE DOCTOR WAS SATISFIED WITH THE RESULTS OF THE MYOSURE DEVICE REMOVING ANY DEBRIS FROM THE CAVITY; NO DEBRIS WAS LEFT IN THE CAVITY. PATIENT WAS FINE AND WAS NOT KEPT FOR ANY FURTHER OBSERVATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20573629 ↗
• InjuryOct 22, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON SEPTEMBER 24 DURING A UTERINE SURGERY A OMNI HYSTEROSCOPIC SCISSOR WAS USED TO TAKE DOWN A SEPTUM. HOWEVER, THE DOCTOR COULDN¿T GET ALL THE WAY THROUGH THE SEPTUM. INSTEAD, THERE WAS A UTERINE PERFORATION WHICH LED TO INTRAABDOMINAL HEMORRHAGE AND THE PATIENT GETTING TRANSFERRED TO CEDARS FOR A LAPAROSCOPY SURGERY. ADDITIONALLY, CUSTOMER REPORTED THAT UTERINE PERFORATION WAS A VERY UNUSUAL COMPLICATION IN WHICH THE DOCTOR HIT A ARTERY IN AN UNUSUAL LOCATION AT THE UTERINE FUNDUS AND IT CAUSED INTRA-ABDOMINAL BLEEDING. DEVICE WORKED AS EXPECTED, NO UNEXPECTED ACTION FROM THE DEVICE OCCURRED AND NO MALFUNCTION WAS REPORTED. PHYSICIAN REPORTED THAT THE EVENT WAS NOT RELATED TO THE SCISSORS BUT WAS AN USER ERROR RELATED TO PATIENT CONDITIONS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 20509004 ↗