M/L-10 1112Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811099010432), received between Jul 15, 2025 and Aug 17, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Difficult to Open or Close

  The hospital found that the titanium clip was continuously clamping or unable to clamp tissue while using the device. The device was then replaced with a new one and did not cause any other impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286267 ↗
• InjuryJan 30, 2026Failure to Fire

  DURING THE ROBOTIC SURGERY IN GASTROINTESTINAL WARD I, IT WAS DISCOVERED THAT THE CLIP APPLICATOR AND TITANIUM CLIP FAILED TO FIRE CONSECUTIVELY (NOT FOR THE FIRST TIME) DURING USE. WHEN ATTEMPTING TO REPLACE THE DISPOSABLE TITANIUM CLIP, IT WAS FOUND THAT THE CLIP APPLICATOR AND TITANIUM CLIP COULD NOT BE SEPARATED. THE CLIP CLAMP CANNOT BE FIRED IN THE ABDOMINAL CAVITY DUE TO CONTINUOUS FIRING. FAILURE TO FIRE DURING SURGERY POSES A RISK OF UNCONTROLLABLE BLEEDING OR DAMAGE TO TISSUES AND BLOOD VESSELS.

  Patient problems: Intra-Abdominal Hemorrhage

  MAUDE report 24223447 ↗
• MalfunctionSep 24, 2025Structural Problem; Structural Problem

  THE PATIENT UNDERWENT A LAPAROSCOPIC RECTAL RESECTION TO ADDRESS AN INTESTINAL MASS. DURING THE PROCEDURE THE CLIP MALFUNCTIONED, A NAIL FAILURE OCCURRED. THE PATIENT SUBSEQUENTLY RECOVERED FROM THE ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23137249 ↗
• MalfunctionAug 7, 2025Failure to Fire; Failure to Fire

  THE PRODUCT WAS LOCKED DOWN, CAN'T BE REMOVED. REPLACED IT WITH A NEW PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 22743229 ↗
• InjuryJul 15, 2025Difficult to Open or Close; Therapeutic or Diagnostic Output Failure; Difficult to Open or Close; Therapeutic or Diagnostic Output Failure

  DURING THE OPERATION, THERE WAS TISSUE BLEEDING AND THE TISSUE WAS CLAMPED WITH THE CONTINUOUS TITANIUM CLIP TO STOP THE BLEEDING. HOWEVER, THE HEMOSTATIC EFFECT WAS NOT GOOD. IT WAS FOUND THAT THE CLIP WAS NOT CLAMPED TIGHTLY AND DID NOT COMPLETELY CLOSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22507699 ↗