AESCULAP PO615RRecalls & reported problems
Aesculap AG · ADTEC MONOPOLAR Grasping Forceps, jaw inserts, straight, (310 mm), diam. 5 mm, serrated (coarse), extra long jaw, single action, reusable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653260256), received between Dec 17, 2020 and Dec 17, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2020Break; Break
InjuryDec 17, 2020Break; Break
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PO615R - JAW INS. ALLIGATOR FORCEPS 5MM 310MM. THE TIP OF AN ALLIGATOR GRASPER DEVICE BROKE OFF INTO THE PATIENT'S ABDOMINAL CAVITY. AFTER A METHODICAL SEARCH AND THE USE OF FLUOROSCOPY X-RAY, THE GRASPING TIP WAS FOUND AND RETRIEVED. THE PROCEDURE WAS DELAYED FOR TEN MINUTES DUE TO THE DEVICE MALFUNCTION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS OCCURRED DURING LAPAROSCOPIC SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11032070 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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