CleanCoat E3773-36CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521550803), received between May 22, 2020 and Oct 27, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Failure to Deliver Energy; Entrapment of Device; Intermittent Energy Output; Failure to Deliver Energy; Entrapment of Device; Intermittent Energy Output

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE STOPPED WORKING. IT DID NOT BURN/WORK PROPERLY. THE TISSUE NEEDS TO BE TORN TO GET IT OFF. IT WAS NOT EASILY REMOVED.

  Patient problems: Tissue Breakdown

  MAUDE report 23397337 ↗
• MalfunctionDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SURGEON DID A FINAL LOOK INTO THE ABDOMEN AND IDENTIFIED A BLUE CAP IN THE PATIENT. THE SURGICAL TECHNICIAN (ST) REMOVED 2 CAPS (1 FROM EACH END) AND DISCARDED IT PRIOR TO CASE START.

  Patient problems: Insufficient Information

  MAUDE report 21018467 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297486 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297454 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297425 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297415 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297393 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297373 ↗
• MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ELECTRODE'S TEFLON FELL OFF OF L-HOOK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297294 ↗
• InjuryFeb 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING DIAGNOSTIC LAPAROSCOPY, THE SURGICAL TECH DID NOT REMOVE THE PLASTIC COVER, IT ENDED UP IN PATIENT AND WAS RECOVERED 18 MONTHS LATER AND IT WAS FULLY RETRIEVED. AN X-RAY WAS REQUIRED TO ASSIST IN LOCATING THE PIECE, THERE WAS REOPERATION TO REMOVE THE PLASTIC COVER, INVESTIGATION REVEALED THE RETAINED FOREIGN OBJECT (RFO) WAS LIKELY THE COVER TO AN L-HOOK ELECTRODE USED IN THE APPENDECTOMY CASE. PATIENT COMPLAINED OF PAIN FROM FOREIGN PROJECT.

  Patient problems: Pain; Unintended Radiation Exposure

  MAUDE report 16419192 ↗
• MalfunctionJul 8, 2020Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE DEVICE SPARKED AND CAUSED A SMALL BURN UNDER THE TROCAR.

  Patient problems: No Information

  MAUDE report 10246842 ↗
• MalfunctionMay 22, 2020Sparking

  PATIENT WAS HAVING SURGERY LAPAROSCOPICALLY WITH A BOVIE AND L HOOK ELECTRODE. THE L-HOOK ELECTRODE SPARKED AND CAUSED A SMALL BURN UNDER THE TROCAR. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Burn, Thermal

  MAUDE report 10086681 ↗