CleanCoat E3771-36CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521550773), received between May 31, 2022 and Jan 2, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ILEAL RESECTION, WHILE OPERATING INSIDE THE ABDOMINAL CAVITY WITH A SMALL INCISION FOR ADHESION DISSECTION, A BLUE FRAGMENT WAS SEEN INSIDE THE ABDOMINAL CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432399 ↗
• MalfunctionMay 31, 2022Loose or Intermittent Connection; Peeled/Delaminated; Loose or Intermittent Connection; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CURVE SPATULA ELECTRODE WAS CONNECTED TO THE PENCIL OF MEDICALNEXT, AND CONNECTED TO THE CONMED SYSTEM 5000 AND USED. BECAUSE THE ELECTRODE GOT UNSTEADY AND THE INSULATION BURNED, IT WAS REPLACED WITH A SPATULA ELECTRODE FROM ANOTHER COMPANY AND USED WITHOUT ANY PROBLEMS. AFTER THE SURGERY, THE ME CONNECTED THE REPORTED SPATULA ELECTRODE TO THE SAME PENCIL AGAIN, WHEN THE ACTIVATION TEST WAS PERFORMED WITH FT10, IT WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14551671 ↗