Senhance X0007029Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815440020187), received between Nov 30, 2023 and Nov 30, 2023 — 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.

• MalfunctionNov 30, 2023Sparking; Sparking

  THE EVENT OCCURRED ON 10/11/2023 AND REPORTED TO ASENSUS ON 10/11/2023. THE EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) HOSPITAL . AS REPORTED BY THE COMPLAINANT, DURING A GYNECOLOGICAL PROCEDURE, IT WAS OBSERVED THAT THE INSULATION FROM THE MONOPOLAR SCISSORS WAS NO LONGER INTACT. THE INSTRUMENT EMITTED SPARKING AND DELIVERED HEAT TO UNWANTED TISSUE AREAS. NO PATIENT HARM WAS REPORTED SINCE THE EVENT WAS NOTICED IN TIME AND THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPY DURING THE LAST SURGICAL STEPS TO AVOID ANY HARM TO THE PATIENT. *NOTE* - ADDITIONALLY, ASENSUS SUBMITTED (B)(4) WITH FILE NAME 3007593944-2023-00014 ON (B)(6) 2023. THE INITIAL REPORT WAS SUBMITTED WITHIN 30 DAYS OF AWARENESS OF THE EVENT BUT SINCE FILE NAME 3007593944-2023-00014 WAS A DUPLICATE, THE SUBMISSION FAILED. ASENSUS ATTEMPTED TO CORRECT THIS ADMINISTRATIVE ERROR, HOWEVER, THE SUBMISSION FAILED ACCORDING TO THE ACKNOWLEDGEMENTS. THIS INITIAL REPORT, FILE NAME IS BEING RESUBMITTED TO CAPTURE THE INCIDENT UNDER THE CORRECT MFR REPORT NUMBER AND THIS SUBMISSION ALSO INCLUDES THE INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240519 ↗