Senhance X0007035Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815440020224), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Sparking” (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 16, 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.

• MalfunctionDec 11, 2024Sparking; Sparking

  NO INJURY OCCURRED TO A PATIENT OR USER. THE EVENT OCCURRED AT (B)(6) IN THE UNITED STATES ON 29-NOV-2024, AND ASENSUS SURGICAL WAS ALSO MADE AWARE ON 29-NOV-2024. THERE WAS A <15 MINUTE DELAY TO THE SURGICAL CASE WITH NO IMPACT TO THE PATIENT, AND THE SURGEON CONVERTED TO TRADITIONAL LAPAROSCOPY TO COMPLETE THE CASE. THE EVENT INFORMATION STATES THAT DURING A SECOND PROCEDURE USING THE SYSTEM ON THIS DATE, THE SURGEON OBSERVED THAT A MONOPOLAR L-HOOK ELECTRODE WAS CONDUCTING ENERGY FROM A SMALL SPOT ON THE SHAFT OF THE INSTRUMENT JUST ABOVE THE TIP. THE INSTRUMENT APPEARED TO BE "ARCHING" ENERGY. THE SURGEON NOTICED A BRIGHT, FLASH-LIKE SPOT ABOUT AN INCH ABOVE THE TIP OF THE INSTRUMENT AS THE INSTRUMENT TOUCHED AN AREA OF FAT NEAR THE GALLBLADDER WHICH PROMPTED THE TEAM TO FURTHER INSPECT THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED AND THE SHAFT COATING WAS NOTICED TO BE PHYSICALLY DAMAGED. NO HARM OR INJURY TO THE PATIENT OCCURRED AS A RESULT OF THIS AND THE INSTRUMENT WAS DEEMED UNUSABLE, AND THE REMAINDER OF THE CASE WAS COMPLETED WITH TRADITIONAL LAPAROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904574 ↗