SurgyCut 790-104-535Recalls & reported problems
U.S. Surgitech Inc. · SurgyCut J - Hook Hand Control Electrode, 5mm/35cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810014631103), received between Aug 23, 2024 and Aug 26, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated3
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2024Peeled/Delaminated; Peeled/Delaminated
J-HOOK ELECTRODE COATING WAS COMING OFF WHEN BEING USED.
Patient problems: Insufficient Information
MAUDE report 20071480 ↗MalfunctionAug 23, 2024Peeled/Delaminated; Peeled/Delaminated
WHILE USING J HOOK IN SURGERY, IT WAS NOTICED THAT IT WAS LEAVING BLUE RESIDUE INSIDE THE ABDOMEN.
Patient problems: Foreign Body In Patient
MAUDE report 20055950 ↗MalfunctionAug 23, 2024Peeled/Delaminated; Peeled/Delaminated
J-HOOK COATING STARTED COMING OFF WHILE IN USE. PERFORMED A LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE PROCEDURE THE J-HOOK COATING BEGAN TO COME OFF WHILE THE SURGEON WAS USING. IT WAS DISCARDED AND A NEW J-HOOK WAS UTILIZED TO CONTINUE THE CASE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20055912 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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