MicroFrance® CEV2295ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10381780092551), received between Sep 9, 2024 and Aug 10, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Melted” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Overheating of Device

  A facility reported that the HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) had a melted sheath. There was no impact to the patient; therefore, no injury, death, or surgical delay was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197699 ↗
• MalfunctionMar 13, 2026Melted

  A FACILITY REPORTED THAT DURING A HYSTERECTOMY, THE BLUE PLASTIC SHEATH ON THE TIP OF THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) MELTED. THERE WAS NO IMPACT ON THE PATIENT, AS THE MELTED SHEATH WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER HOOK. NO INJURY OR DEATH WAS REPORTED, ALTHOUGH THERE WAS A SLIGHT INCREASE IN SURGICAL TIME BY A FEW MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589357 ↗
• MalfunctionNov 24, 2025Melted; Melted

  A FACILITY REPORTED THAT THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) MELTED AT ITS ENDS. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT, INJURY, DEATH, OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631387 ↗
• MalfunctionNov 14, 2025Melted; Melted

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557889 ↗
• MalfunctionNov 11, 2025Melted; Melted

  A FACILITY REPORTED THAT THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) TIPS MELTED AT THE DISTAL PART OF THE BLUE INSULATION ON THE HOOK SIDE. THE TIPS ARE NEW AND IN THEIR FIRST USE, THE METAL PART BLACKENED RATHER QUICKLY. THE DISTRIBUTOR HAS ASKED THE CUSTOMER TO ENSURE THAT THE MONOPOLAR VOLTAGE USED IS REASONABLE AND REFERRED THEM TO THE RELEVANT INSTRUCTIONS FOR USE. ALTHOUGH THE PRODUCT WAS IN CONTACT WITH THE PATIENT, THERE WERE NO INJURIES OR AN INCREASE IN SURGICAL TIME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524276 ↗
• MalfunctionMay 21, 2025Melted; Melted

  IT WAS REPORTED THAT THE 3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) MELTED DURING A PROCEDURE. GENERATOR ASSESSMENT WAS PERFORMED BY A 3RD PARTY MAINTENANCE COMPANY AND NAMED SUPPLIER. THE "SUPPLIER'S ASSESSMENT APPEARS TO BE COMPLIANT." THE ISSUE IDENTIFIED WAS "LACK OF KNOWLEDGE OF ELECTROSURGERY SETTINGS, WHICH MAY HAVE CAUSED AN OVER VOLTAGE BEYOND THE HOOK'S TOLERANCE". IT WAS REPORTED THAT THERE WAS RISK OF BURN AND RISK OF PLASTIC PARTICLES FALLING INTO THE PATIENT; HOWEVER, NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059949 ↗
• MalfunctionMar 31, 2025Melted; Melted

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732055 ↗
• MalfunctionMar 27, 2025Melted; Melted

  IT WAS REPORTED THAT DURING INTERVENTION, THE SHEATH SURROUNDING THE HOOK FOR HOOK HANDLE (CEV2295A) MELTED. ANOTHER PRODUCT WAS AVAILABLE FOR USE. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. IT WAS NOTED THAT THE CUSTOMER HAS THEIR PRODUCT REPAIRED BY AN EXTERNAL COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707667 ↗
• MalfunctionMar 24, 2025Melted; Melted

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679233 ↗
• MalfunctionMar 15, 2025Melted; Melted

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613089 ↗
• MalfunctionOct 21, 2024Melted; Melted

  SEE H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500790 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500220 ↗
• MalfunctionOct 21, 2024Overheating of Device; Overheating of Device

  THIS REPORT IS 1 OF 2, FOR THE FIRST 380MM DIA5MM HOOK HANDLE (B)(6) REPORTEDLY USED DURING THIS EVENT AND IS RELATED TO MFG# 3003249645-2024-00053: IT WAS REPORTED THAT "DURING A HYSTERECTOMY, THE HOOK MELTED." THIS HAPPENED TWICE. IT WAS REPORTED THAT NO PART DETACHED FROM THE HOOK. THERE WAS NO IMPACT TO THE PATIENT, AS STAFF COULD COMPLETE THE SURGERY WITH A THIRD HOOK. SURGERY TIME WAS INCREASED BY FIVE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496143 ↗
• MalfunctionSep 9, 2024Melted; Melted

  IT WAS REPORTED THAT THE COELIO HOOKS/3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) MELTED DURING USE. NO INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170427 ↗