Senhance X0007306Recalls & reported problems
Asensus Surgical, Inc. · Bipolar Grasping Forceps · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815440021627), received between Dec 19, 2023 and Dec 19, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2023Sparking; Sparking
ON 17-MAR-2022 AT (B)(6) IN JAPAN, IT WAS REPORTED IN ((B)(4)) THAT DURING A PARTIAL HEPATECTOMY (SEGMENT IV), THE INSTRUMENT (X0007306-BISSINGER BIPOLAR GRASPING FORCEPS) SPARKED ELECTRICITY DURING USE FROM THE HINGE AT THE BASE OF THE TIP AND THE INSTRUMENT STOPPED WORKING. THE SITE OR NURSE COMMENTED THAT THE INSTRUMENT MAY BE DEFECTIVE BECAUSE IT HAD BEEN USED ONLY A FEW TIMES SINCE DELIVERY. THERE WAS NO IMPACT TO THE PATIENT OR THE SURGICAL CASE, AND THE OPERATION WAS COMPLETED WITH THE SENHANCE SYSTEM. ASENSUS SURGICAL REPORTED A SIMILAR COMPLAINT ((B)(4)) ON 30-NOV-2023, WHICH LED THE COMPANY TO REEVALUATE PREVIOUS COMPLAINTS WITH SIMILAR OCCURRENCES OF INSTRUMENT SPARKING. IN COMPLAINT ((B)(4)), THE ROOT CAUSE WAS ATTRIBUTED TO WEAR AND TEAR OF THE INSULATION PART OF THE INSTRUMENT. MOREOVER, TWO SIMILAR COMPLAINTS ((B)(4)) WERE REPORTED PRIOR TO THIS COMPLAINT THAT ALSO REPORTED SPARKING. THEIR ROOT CAUSE WAS ATTRIBUTED TO HUMAN ERROR, DUE TO THE USER TOUCHING TWO METALLIC INSTRUMENT TIPS TOGETHER DURING ENERGY APPLICATION. ALTHOUGH THERE WAS NO IMPACT ON THE PATIENT IN THIS PARTICULAR EVENT, THE MALFUNCTION OF THE DEVICE IS COMPATIBLE WITH THE DEFINITION FOR A SERIOUS IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18356378 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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