AESCULAP US614Recalls & reported problems
Aesculap, Inc. · HARDY ROSE GOLD Bipolar Forceps, straight, 8 1/2", (215 mm), working length: 4 1/2", (115 mm), bayonet-shaped, insulated, width: 2 mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964161773), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Skin Tears1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO AESCULAP INC. THAT A GOLDTIP BIPOLAR FCPS STR 215/115/2.0MM (PART # US614) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE GOLD COATING ON THE FORCEPS' TIP IS FLAKING CAUSING TISSUE TO STICK WHICH RESULTED IN TEARING/PULLING AND A RESTART OF BLEEDING WHEN THE DEVICE WAS WITHDRAWN. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Tears
MAUDE report 14653307 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.