ADTEC SOVEREIGN PL232RRecalls & reported problems
Aesculap AG · ADTEC SOVEREIGN Grasping Forceps, complete instrument, (360 mm), diam. 5 mm, with sliding ratchet, double action, reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04046964074851), received between Sep 11, 2024 and Sep 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP INC. THAT A SOVEREIGN ATR.GRASP.FCPS D:5/360MM W/RAT. (PART# PL232R) WAS USED DURING A ROBOTIC HYSTERECTOMY AND SACRAL COLPOPEXY PROCEDURE. ACCORDING TO THE COMPLAINANT THE JAW OF THE INSTRUMENT BROKE DURING THE PROCEDURE. THERE WERE NO PIECES THAT DETACHED OR WERE RETRIEVED; AN X-RAY WAS TAKEN AND RESULTS CONFIRMED THAT NO FRAGMENTS REMAINED IN SITU. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189776 ↗
Other FORCEPS devices
- NA 314.291Synthes GmbH · FORCEPS177 reports
- NA 399.99Synthes GmbH · FORCEPS111 reports
- NA PDL114Synthes GmbH · FORCEPS81 reports
- GEM COUPLER Forceps GEM4183CSynovis Micro Companies Alliance, Inc · FORCEPS1 recall4 reports
- AESCULAP BJ043RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP MD569Aesculap, Inc. · FORCEPS1 recall0 reports
- ATRAUMATA FB483RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ045RAesculap AG · FORCEPS1 recall0 reports
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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