CoolSeal™ Mini CSL-MN103-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850346007085), received between Feb 12, 2023 and Sep 10, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Pneumothorax

  MAUDE report 50723321 ↗
• MalfunctionJul 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A COOLSEAL MINI PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT UPON FIRST USE, THE INSTRUMENT CLICKED WHEN INSERTED AND OPENED BUT FAILED TO CLOSE. A SMALL PIECE FROM THE JAW MECHANISM FELL INTO THE OPERATIVE FIELD AND AS A RESULT THE JAWS WOULD NOT CLOSE AFTERWARDS TO REMOVE THE INSTRUMENT FROM THE PATIENT. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22637368 ↗
• MalfunctionOct 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A COOLSEAL MINI PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT A SMALL PIECE BROKE OFF THE DEVICE MID PROCEDURE. GRASPERS WERE USED TO REMOVE THE PIECE SINCE IT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363603 ↗
• InjuryJun 22, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A COOLSEAL MINI PROCEDURE INVOLVING A THORACOTOMY/LOBECTOMY IN A PEDIATRIC PATIENT, THE PHYSICIAN REPORTED THAT THE DEVICE BURNED THE PATIENT´S LUNG TISSUE. THE PROCEDURE WAS REPORTED COMPLETED SUCCESSFULLY WITH A SECOND DEVICE. NO MEDICAL TREATMENT REQUIRED AFTER THE PROCEDURE AND NO ADDITIONAL HOSPITALIZATION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 17186542 ↗
• InjuryFeb 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION ON (B)(6) 2022 , THE PHYSICIAN REPORTED THAT UPON ACTIVATION OF THE DEVICE, HEAT WAS TRANSMITTED TO THE ADJACENT TISSUE. PHYSICIAN REPORTS THAT THE INSTRUMENT CAUSED MINOR BLANCHING TO THE LIVER. NO OTHER INJURIES WERE REPORTED AND THE PATIENT WAS DOING WELL. THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT. NO ADDITIONAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16359970 ↗