BANTAM / PRO A942Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607151011178), received between Feb 25, 2021 and Feb 22, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER ALLEGED THAT DURING HOMEOSTASIS OF THE LEFT EYELID PTOSIS SURGERY. THE BIPOLAR WAS ACTIVATED AND DISCHARGED FROM THE TIP. THE PATIENT'S EYELASHES BURNED DUE TO THE ACTIVATION. DURING THIS PROCEDURE, THE SURGEON TURNS THE EYELID INSIDE OUT AND SHORTENS THE EYELID MUSCLES FROM THE INSIDE OF THE EYELID. THERE IS POSSIBILITY THAT THE PATIENT COULD HAVE INFLAMMATION OR BURNS OVER TIME, BUT THERE WERE NO OBVIOUS BURNS CONFIRMED IMMEDIATELY AFTER THE INCIDENT. THE EYELID SURGERY WAS COMPLETED INCLUDING SUTURING AND THE AREA AROUND THE LEFT EYE WAS TREATED WITH COOLING AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421958 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER ALLEGED THAT THE NURSE EXPERIENCED AN ELECTRICAL BURN WHILE SHE WAS HOLDING THE SKIN AWAY FROM THE TIP BY NON-INSULATED FORCEPS.

  Patient problems: Burn, Thermal

  MAUDE report 11379775 ↗