Standard Clamp, Disposable SCD25-1Recalls & reported problems
Standard Bariatrics, Inc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851677007003), received between Mar 1, 2018 and Mar 1, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem2
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2018Mechanical Problem; Mechanical Problem
THE STANDARD CLAMP, DISPOSABLE WAS BEING USED IN A SLEEVE GASTRECTOMY PROCEDURE TO GRASP AND CLAMP THE STOMACH. THE PHYSICIAN OPENED THE CLAMP JAWS AND WAS UNABLE TO CLOSE THEM BY ACTIVATING THE TRIGGER ON THE HANDPIECE. THE USER MANUALLY CLOSED THE JAWS AND REMOVED THE DEVICE FROM THE TROCAR. THE DEVICE WAS REPLACED WITH A NEW STANDARD CLAMP, DISPOSABLE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. NO ADVERSE EVENT OCCURRED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7306263 ↗MalfunctionMar 1, 2018Mechanical Problem; Mechanical Problem
THE STANDARD CLAMP, DISPOSABLE WAS BEING USED IN A SLEEVE GASTRECTOMY PROCEDURE TO GRASP AND CLAMP THE STOMACH. THE PHYSICIAN OPENED THE CLAMP JAWS AND WAS UNABLE TO FULLY CLOSE THEM BY ACTIVATING THE TRIGGER ON THE HANDPIECE (JAWS CLOSED PARTIALLY). THE USER MANUALLY CLOSED THE JAWS AND REMOVED THE DEVICE FROM THE TROCAR. THE DEVICE WAS REPLACED WITH A NEW STANDARD CLAMP, DISPOSABLE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. NO ADVERSE EVENT OCCURRED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7306261 ↗
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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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