Megadyne ME7251STRecalls & reported problems
Megadyne Medical Products, Inc. · Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10614559105955), received between Mar 5, 2025 and Mar 17, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Activation3
- Appropriate Device Problem Term/Code Not Available1
- Patient Device Interaction Problem1
Patient problems
- Partial thickness (Second Degree) Burn3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT DURING A MASTECTOMY PROCEDURE PERFORMED BY THE SURGICAL TEAM, A PLASTIC SURGEON WAS BROUGHT IN TO COMPLETE THE RECONSTRUCTION USING A SOFT TISSUE DISSECTOR. UPON ASSESSMENT, THE PLASTIC SURGEON NOTED AREAS OF BLISTERING AND MILD SIGNS OF DECREASED VASCULARIZATION WITHIN THE TISSUE. DESPITE THESE FINDINGS, THE RECONSTRUCTION WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT DEVELOPED ISSUES RELATED TO THE VIABILITY OF THE RECONSTRUCTED TISSUE. DUE TO THESE COMPLICATIONS, THE CLINICAL TEAM DETERMINED THAT THE PATIENT WOULD NEED TO RETURN TO THE OPERATING ROOM FOR REVISION SURGERY AND A REDO OF THE FLAP.
Patient problems: Unspecified Tissue Injury
MAUDE report 24617267 ↗MalfunctionMar 5, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21528881 ↗MalfunctionMar 5, 2025Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available; Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Partial thickness (Second Degree) Burn
MAUDE report 21528734 ↗MalfunctionMar 5, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT DURING A CADAVER LAB THE BOVIE WERE AROUND 30 CUT 30 COAG. THE SURGEON GOT BURNED THROUGH THEIR GLOVES.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 21528640 ↗
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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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