Senhance X0007309Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815440021634), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Break; Degraded; Break; Degraded

  DATE OF THE INCIDENT: (B)(6) 2025. DATE OF AWARENESS: 25-JUNE-2025. LOCATION: (B)(6) HOSPITAL, (B)(6). DEVICE NAME: 3MM BIPOLAR INSTRUMENT. ACCORDING TO THE EVENT INFORMATION, DURING THE SIMULATION TRAINING SESSION, 3MM BIPOLAR INSTRUMENT WAS USED WITHOUT ANY PROBLEMS. DURING THE SIMULATION TRAINING, NO ISSUES OR MALFUNCTIONS WITH THE INSTRUMENT WAS OBSERVED. HOWEVER, DURING CLEANING, THE STAFF DISCOVERED THE HINGE TO BE BURNT/DISCOLORED. THE TRAINING WAS PERFORMED ON A SIMULATED ORGAN MODEL MADE OF A WATER BASED GEL. THE COMPLAINANT ALSO REPORTED THAT IT WAS THE FIRST USE OF THE INSTRUMENT, AND THE ESU SETTING WAS 30W. SINCE THE ISSUE OCCURRED DURING TRAINING, THERE WAS NO PATIENT HARM OR SURGICAL CASE IMPACT REPORTED. NO SPARKS WERE IDENTIFIED DURING THE USE OF THE INSTRUMENT. THE INVESTIGATION OF THE ISSUE IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509316 ↗