CoolSeal™ Trinity CSL-TR105-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00850346007047), received between Apr 30, 2021 and Aug 26, 2026 — classified as 19 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Failure to Seal

  It was reported that during a CoolSeal Trinity procedure on (b)(6) 2026, the physician reported that during the procedure the device did not seal sufficiently which caused bleeding (Less than 1 ml). The device was exchanged and the procedure was completed without any further issues. No other information available.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50454156 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING A SALPINGO-OOPHORECTOMY USING A COOLSEAL TRINITY, THE PHYSICIAN REPORTED THAT WHILE CUTTING ONE OF THE FALLOPIAN TUBES THE DEVICE CUT BUT DID NOT SEAL AND THE FALLOPIAN TUBE STARTED TO BLEED WITH AN APPROXIMATE BLOOD LOSS OF 50ML. THE TISSUE WAS NOT BLANCHED. AT THIS POINT ANOTHER COOLSEAL TRINITY WAS USED BUT DID NOT PROVIDE A GOOD SEAL TONE. AT THIS POINT A THIRD-PARTY DEVICE (LIGASURE) WAS USED TO COMPLETE THE CASE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25447415 ↗
• InjuryMar 25, 2026Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOLSEAL TRINITY ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE DEVICE WAS NOT SEALING SUFFICIENTLY AND CAUSED BLEEDING FROM SMALL VESSELS AND WERE OOZING MORE THAN NORMAL. THE EXACT AMOUNT OF BLOOD COULD NOT BE QUANTIFIED. THE PHYSICIAN DECIDED TO SWITH TO ANOTHER MODALITY OF DEVICE AND WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED AT THE END OF PROCEDURE. PATIENT WAS DISCHARGED AS NORMAL PROTOCOL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24688283 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A COOLSEAL PROCEDURE IN A CHOLECYSTECTOMY WAS BEING PERFORMED THE PHYSICIAN ATTEMPTED TO CREATED A SEAL ON THE MESENTERY AND SAW BLEEDING. THE PHYSICIAN REPORTED THAT BLEEDING WAS OBSERVED AFTER THE INADEQUATE SEAL AND ANOTHER SEALER WAS USED TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20620159 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A COOLSEAL PROCEDURE IN WHICH MESENTERY WAS BEING CUT THE PHYSICIAN ATTEMPTED TO CREATED A SEAL ON THE MESENTERY AND SAW BLEEDING. THE PHYSICIAN REPORTED THAT BLEEDING WAS OBSERVED AFTER THE INADEQUATE SEAL AND ANOTHER SEALER WAS USED TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20620150 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JULY 10TH, 2024, DURING A SALPINGECTOMY- OOPHORECTOMY, THE PHYSICIAN STARTED TO TAKE SEALS AROUND THE TUBE AND THEN OVARY. TRINITY DEVICE SEEMED TO SEAL FINE AT FIRST BUT SECONDS LATER THE PHYSICIAN NOTICED SEVERE BLEEDING STARTING TO HAPPEN AROUND THE OVARIAN ARTERY. STAFF COULD NOT CONFIRM IF THE SEAL LINE BROKE. THE SURGEON ATTEMPTED TO SEAL MULTIPLE TIMES USING THE TRINITY, BUT THE BLEEDING CONTINUED, AND THEY HAD TO SWITCH TO LIGASURE AND WAS ABLE TO CONTROL THE BLEEDING. THE PROCEDURE WAS COMPLETED USING LIGASURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19912828 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), A PROCEDURE WAS PERFORMED WITH A COOLSEAL TRINITY AND THE DEVICE KEPT SLIPPING OUT OF THE JAWS DURING THE SEALING PROCESS, THE HANDLES WERE LOCKED AND STILL SLIPPED. THEY USED GRASPERS TO PULL MORE TISSUE INTO THE JAWS TO PREVENT SLIPPING, WHICH HELPED ON THE FIRST SIDE. THEY GOT TO THE SECOND SIDE AND THE DEVICE DID NOT SLIP, BUT HAD BLEEDING. THEY HAD TO USE SURGICAL SNOW TO HELP CONTROL THE BLEEDING. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18421985 ↗
• MalfunctionDec 29, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON DECEMBER 7TH A PROCEDURE WITH A COOLSEAL TRINITY WAS PERFORMED AND DURING THE PROCEDURE, THE DEVICE BROKE. THE JAWS BROKE AND FELL INSIDE THE PATIENT. THE DEVICE WAS STUCK OPEN, THE SURGEONS WERE ABLE TO RETRIEVE THE DEVICE BY GETTING AN ADDITIONAL DEVICE TO CLOSE THE JAWS TO THEN REMOVE OUT TROCAR, AND A WIRE PIECE FROM THE LINK FELL INTO THE PELVIS OF THE PATIENT AND HAD TO RETRIEVE THAT SEPARATELY. NO INJURY TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416967 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) A HYSTEROCTOMY WAS PERFORMED WITH A COOLSEAL TRINITY DEVICE, AND THE DEVICE BROKE AND THE JAWS LOCKED IN POSITION. THE DOCTOR HAD TO USE A TROCAR TO GET THE DEVICE OUT AND THE PROCEDURE WAS COMPLETED WITH A SECOND COOLSEAL TRINITY. NO INJURY TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683510 ↗
• MalfunctionJun 8, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A COOLSEAL PROCEDURE ON (B)(6) 2023, THE TIP OF THE DEVICE BROKE OFF IN PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO REMOVE THE PIECES FROM THE PATIENT AND USED A SECOND DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17092027 ↗
• MalfunctionFeb 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A COOL SEAL TRINITY PROCEDURE, PIECES FROM THE JAWS BROKE OFF AND WERE FOUND IN THE BELLY OF THE PATIENT. PIECES WERE REMOVED AND THE PATIENT WAS STABLE. NO INJURY REPORTED TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456345 ↗
• InjuryFeb 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON DECEMBER 19TH A PATIENT RECEIVED A LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO OVARECTOMY IN WHICH A COOL SEAL TRINITY 37 WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED THE NEXT DAY. HOWEVER PATIENT WAS ADMITTED THE NEXT DAY WITH A HEMATOMA (14X8X7 CM) AND LOW HEMOGLOBIN LEVELS. PATIENT WAS GIVEN A BLOOD TRANSFUSION AND SPENT A FEW DAYS IN THE HOSPITAL BEFORE BEING DISCHARGED. THE CAUSE OF BHE BLEEDING COULD NOT BE CLINICALLY IDENTIFIED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL SURGICAL INTERVENTION AND IT WAS REPORTED AS FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16359950 ↗
• MalfunctionFeb 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023 , DURING A COOL SEAL TRINITY PROCEDURE , TINY PIECES FROM THE JAWS BROKE OFF AND WERE FOUND IN THE BELLY OF THE PATIENT. PIECES WERE REMOVED AND THE PATIENT WAS STABLE. NO INJURY REPORTED TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286078 ↗
• MalfunctionFeb 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023 , DURING A COOL SEAL TRINITY PROCEDURE , TINY PIECES FROM THE JAWS BROKE OFF AND WERE FOUND IN THE BELLY OF THE PATIENT. PIECES WERE REMOVED AND THE PATIENT WAS STABLE. NO INJURY REPORTED TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286077 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MAY 27TH DURING A COOL SEAL PROCEDURE , THE PHYSICIAN REPORTED THAT WHILE SEALING CLOSE TO THE UTERUS , THE COOLSEAL JAWS WERE POSITIONED CURVED TOWARDS THE UTERUS AND THE TIP PERFORATED THE UTERUS CAUSING BLEEDING. THE PHYSICIAN SWITCHED TO A 3RD PARTY DEVICE TO COMPLETE THE CASE. PATIENT WAS REPORTED DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 14687271 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOL SEAL TRINITY PROCEDURE ON MAY 24TH AT THE START OF THE CASE THE SURGEON COMMENTED THAT THE PATIENT HAD VERY LARGE VESSELS AND VERICOSE VEINS AND THAT THIS WOULD BE A CHALLENGING CASE. THE SEALER WORKED WELL AT THE START BUT SIGNIFICANT BLEEDING OCCURRED NEAR THE UTERINE ARTERY. THE PHYSICIAN SKELETONIZED THE UTERINE ARTERY AND SEALED 6 TIMES ALONG THE VESSEL BEFORE CUTTING. THE SURGEON STRUGGLED TO GET THE BLEEDING UNDER CONTROL AND ASKED FOR A 3RD PARTY DEVICE TO FINISH THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14687144 ↗
• MalfunctionJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOL SEAL PROCEDURE IN A LAPAROSCOPIC HYSTERECTOMY , THE SEALER SEEMED TO WORK FINE AT THE START OF THE PROCEDURE, BUT AS THE CASE PROGRESSED BLEEDING OCCURED AT SEVERAL SITES WHERE THE VESSELS WERE PREVIOUSLY SEALED. THE PHYSICIAN WAS ABLE TO STOP THE BLEEDING USING COOLSEAL BUT THERE WAS BLEEDING REPORTED. NO HARM WAS REPORTED TO THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14686939 ↗
• MalfunctionJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BETWEEN MAY 13 AND MAY 16TH A PHYSICIAN HAD 2 CASES OF 1 BAD SEALING AND 1 CASE WERE THE DEVICE STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE. ANOTHER DEVICE HAD TO BE USED TO STOP THE BLEEDING. NO HARM REPORTED . 4 DEVICES WERE USED TOTAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14686630 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BETWEEN MAY 13 AND MAY 16TH A PHYSICIAN HAD 2 CASES OF 1 BAD SEALING AND 1 CASE WERE THE DEVICE STOPPED WOKING IN THE MIDDLE OF THE PROCEDURE. ANOTHER DEVICE HAD TO BE USED TO STOP THE BLEEDING. NO HARM REPORTED . 4 DEVICES WERE USED TOTAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14686574 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BETWEEN MAY 13 AND MAY 16TH A PHYSICIAN HAD 2 CASES OF 1 BAD SEALING AND 1 CASE WERE THE DEVICE STOPPED WOKING IN THE MIDDLE OF THE PROCEDURE. ANOTHER DEVICE HAD TO BE USED TO STOP THE BLEEDING. NO HARM REPORTED. 4 DEVICES WERE USED TOTAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14686568 ↗
• MalfunctionJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BETWEEN MAY 13 AND MAY 16TH A PHYSICIAN HAD 2 CASES OF 1 BAD SEALING AND 1 CASE WERE THE DEVICE STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE. ANOTHER DEVICE HAD TO BE USED TO STOP THE BLEEDING. NO HARM REPORTED . 4 DEVICES WERE USED TOTAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14686532 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A TRINITY PROCEDURE AFTER THE CUT THE PHYSICIAN NOTICED THAT THE CUT SURFACE OF THE ARTERY SEEMED ¨PINKIER¨ THAN USUAL AND OOZING. THE PHYSICIAN BROUGHT IN A CONVENTIONAL BIPOLAR INSTRUMENT TO COAGULATE THE CUT ARTERY ADDITIONALLY. LATER THIS ARTERIAL TISSUE BROKE AND CAUSED BLEEDING. THE PHYSICIAN HAD TO DISSECT THE ARTERY FURTHER AND TIED IT WITH A SUTURE. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE. NON-PEDIATRIC PATIENT AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14626256 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A TRINITY PROCEDURE AFTER THE CUT THE PHYSICIAN NOTICED THAT THE CUT SURFACE OF THE ARTERY SEEMED ¨PINKIER¨ THAN USUAL AND OOZING. THE PHYSICIAN BROUGHT IN A CONVENTIONAL BIPOLAR INSTRUMENT TO COAGULATE THE CUT ARTERY ADDITIONALLY. LATER THIS ARTERIAL TISSUE BROKE AND CAUSED BLEEDING. THE PHYSICIAN HAD TO DISSECT THE ARTERY FURTHER AND TIED IT WITH A SUTURE. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE. NON-PEDIATRIC PATIENT AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14517641 ↗
• InjuryApr 15, 2022Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  IT WAS REPORTED THAT THE TRINITY SEALER STOPPED SEALING AFTER 100-300+ SEALS. AFTER PERFORMING AS EXPECTED FOR THE FIRST PART OF THE SURGERY, THE DEVICE WAS CLEANED. AFTER THIS IT WAS REPORTED THAT THE DEVICE "WOULD NOT COAGULATE BUT DID CUT". THE PATIENT THEN PRESENTED AN ARTERIAL BLEEDER. ANOTHER DEVICE WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. AFTER THE PROCEDURE, A WIRE PROTRUSION WAS OBSERVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14124213 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTRUMENT WAS GIVING GOOD SEALING TONES (SEAL COMPLETE TONE), BUT THERE WAS BLEEDING OBSERVED FROM CUTTING SURFACES. FOLLOWING THIS THE GENERATOR PROVIDED INCOMPLETE SEALING ALERTS (REACTIVATE / INCOMPLETE SEAL TONE), THE DEVICE WAS NOT SEALING. PATIENT INFORMATION IS UNAVAILABLE AS IT IS NOT ALLOWED TO PUBLISH ACCORDING TO (B)(6) RULES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14057195 ↗