CoolSeal™ Reveal CSL-RV105-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00850346007092), received between Oct 10, 2022 and Sep 14, 2026 — classified as 1 death, 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Disposable cool seal trigger broke off.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754740 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PHYSICIAN THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, WHILE USING A COOLSEAL REVEAL, THE PHYSICIAN HAD OBSERVED THAT FLUID IN THE AREA OF THE JAWS WOULD GET HOT AND AROUND THE AREA OF INCISION, THE PHYSICIAN OBSERVED SOME SKIN BURNS. IT IS UNKNOWN ON HOW MANY PATIENTS, DATES AND PROCEDURES IN WHICH THIS HAS HAPPENED AS THE PHYSICIAN DID NOT SPECIFY. THE PHYSICIAN REPORTED THAT ELECTROLUBE WAS USED TO PREVENT FROM STICKING. NO REPORTS OF ADDITIONAL INTERVENTIONS OR INJURIES. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 24442629 ↗
• MalfunctionJan 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A COOLSEAL REVEAL PROCEDURE ON AN UNKNOWN DATE, THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE THE BLADE FELL OUT OF THE DEVICE INSIDE THE PATIENT. IT IS UNKNOWN WHICH PROCEDURE WAS BEING PERFORMED. NO INCIDENT WAS REPORTED AND NO HARM WAS REPORTED TO THE PATIENT NOR ANY MEDICAL INTERVENTION REQUIRED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION WHICH WERE NOT RESPONDED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21129837 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON STATED THAT 2 OUT OF 3 PATIENTS THAT WERE TREATED WITH THE COOLSEAL REVEAL WENT TO THE EMERGENCY ROOM WITH BLEEDING AT THE SURGICAL SITE, A FEW DAYS AFTER THE PROCEDURES. PROCEDURES PERFORMED WERE : LEFT THYROID LOBE, RIGHT THYROID LOBE AND TOTAL THYROID IT IS UNKNOWN WHICH PROCEDURE WAS REPORTED FOR THE SPECIFIC PROCEDURE AS PHYSICIAN DID NOT WANT TO BE CONTACTED AGAIN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20568407 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON STATED THAT 2 OUT OF 3 PATIENTS THAT WERE TREATED WITH THE COOLSEAL REVEAL WENT TO THE EMERGENCY ROOM WITH BLEEDING AT THE SURGICAL SITE, A FEW DAYS AFTER THE PROCEDURES. PROCEDURES PERFORMED WERE: LEFT THYROID LOBE, RIGHT THYROID LOBE AND TOTAL THYROID IT IS UNKNOWN WHICH PROCEDURE WAS REPORTED FOR THE SPECIFIC PROCEDURE AS PHYSICIAN DID NOT WANT TO BE CONTACTED AGAIN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20568303 ↗
• MalfunctionAug 9, 2024

  COOLSEAL WAS BEING USED BY PHYSICIAN AND THUMB LEVER BROKE OFF, HIT THE PHYSICIAN IN THE HEAD AND FELL ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948936 ↗
• InjuryJul 22, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT DURING A COOLSEAL REVEAL PROCEDURE ON (B)(6) 2024, THE SURGEON REPORTED THAT THEY COULD NOT SEAL SMALL VESSELS DURING A THYROIDECTOMY. SURGEON REPORTED THAT THERE WAS AN UNCONTROLLED BLEEDING FROM SMALL VESSELS WHICH WAS EASILY MANAGED BUT PROBLEMATIC, THEY HAD TO USE A HARMONIC TO CONTROL THE BLEEDING. PATIENT WAS DOING FINE. NO OTHER COMPLICATIONS WERE REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19793111 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), AN OPEN RIGHT SELECTIVE NECK DISSECTION WAS PERFORMED, AND DURING THE PROCEDURE, THERE WAS NO INCIDENT OR DELAY IN THE CASE. THERE WERE NO POTENTIAL ADVERSE EVENTS AND THE PROCEDURE WAS COMPLETED WITHOUT INJURY. OVER THE WEEKEND THE DOCTOR RECEIVED THE PATIENT WITH A HEMATOMA. THE PATIENT HAD AN ADDITIONAL SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 19213160 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6), THAT A PARTIAL THYROIDECTOMY PROCEDURE WAS PERFORMED WITH A COOLSEAL REVEAL AND THE PATIENT PRESENTED WITH BLEEDING AT HOME AND HAD TO BE RUSHED TO THE HOSPITAL, AND WAS DISCHARGED THE NEXT DAY. SURGEONS AND STAFF IN THE ROOM DID NOT ATTRIBUTE/OR COULDN¿T SAY IF THE BLEEDING WAS DUE TO THE REVEAL, OR ANY OF THE TOOLS USED IN THE ROOM, MOSTLY ATTRIBUTED THE BLEEDING DUE TO PATIENT FACTORS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17590853 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT RECEIVED A PARATHYROIDECTOMY AND WAS RELEASED TO SAME DAY WITHOUT ANY SYMPTOMS. THE SURGERY WAS REPORTED AS UNREMARKABLE. THE DEVICE USED IN THE PROCEDURE WAS DISCARDED. THE PATIENT HAD TO COME BACK TO THE EMERGENCY ROOM BETWEEN 1 TO 3 DAYS POST OPERATION AND REQUIRED A SURGICAL REINTERVENTION DUE TO THE PRESENCE OF BLEEDING AND HEMATOMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17461962 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT RECEIVED A PARATHYROIDECTOMY AND WAS RELEASED TO SAME DAY WITHOUT ANY SYMPTOMS. THE SURGERY WAS REPORTED AS UNREMARKABLE. THE DEVICE USED IN THE PROCEDURE WAS DISCARDED. THE PATIENT HAD TO COME BACK TO THE EMERGENCY ROOM BETWEEN 1 TO 3 DAYS POST OPERATION AND REQUIRED A SURGICAL REINTERVENTION DUE TO THE PRESENCE OF BLEEDING AND HEMATOMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17461844 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT RECEIVED A THYROIDECTOMY AND WAS RELEASED TO SAME DAY WITHOUT ANY SYMPTOMS. THE SURGERY WAS REPORTED AS UNREMARKABLE. THE DEVICE USED IN THE PROCEDURE WAS DISCARDED. THE PATIENT HAD TO COME BACK TO THE EMERGENCY ROOM BETWEEN 1 TO 3 DAYS POST OPERATION AND REQUIRED A SURGICAL REINTERVENTION DUE TO THE PRESENCE OF BLEEDING AND HEMATOMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17461810 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT RECEIVED A RADICAL NECK DISSECTION AND WAS RELEASED TO SAME DAY WITHOUT ANY SYMPTOMS. THE SURGERY WAS REPORTED AS UNREMARKABLE. THE DEVICE USED IN THE PROCEDURE WAS DISCARDED. THE PATIENT HAD TO COME BACK TO THE EMERGENCY ROOM BETWEEN 1 TO 3 DAYS POST OPERATION AND REQUIRED A SURGICAL REINTERVENTION DUE TO THE PRESENCE OF BLEEDING AND HEMATOMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17461765 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT RECEIVED A THYROIDECTOMY AND WAS RELEASED TO SAME DAY WITHOUT ANY SYMPTOMS. THE SURGERY WAS REPORTED AS UNREMARKABLE. THE DEVICE USED IN THE PROCEDURE WAS DISCARDED. THE PATIENT HAD TO COME BACK TO THE EMERGENCY ROOM BETWEEN 1 TO 3 DAYS POST OPERATION AND REQUIRED A SURGICAL REINTERVENTION DUE TO THE PRESENCE OF BLEEDING AND HEMATOMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17461390 ↗
• DeathJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE (WITHIN THE LAST FEW MONTHS) A PATIENT REQUIRED A THYROID SURGERY INVOLVING A COOLSEAL REVEAL, AND IT IS UNKNOWN IF THE PATIENT HAD ANY COMPLICATIONS DURING THE PROCEDURE BUT THE TECH CONFIRMED THAT THE PATIENT WAS SENT HOME POST PROCEDURE. THEN THEN PATIENT RETURNED TO THE ER AND WAITED 3 HOURS TO BE READMITTED (CAUSES ARE UNKNOWN) THE PATIENT WAS REPORTED AS¨ BLEEDING TOO MUCH¨ AND THE PATIENT LATER DIED. THE CAUSE OF THE DEATH IS UNKNOWN AND IT IS UNKNOWN WHAT WERE THE SYMPTOMS THAT REQUIRED THE PATIENT TO COME BACK TO THE ER. THE DATE OF THE DEATH IS UNKNOWN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17372375 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PARATHYROIDECTOMY IN WHICH THE PHYSICIAN WAS USING A COOLSEAL REVEAL, THE PHYSICIAN REPORTED THAT HE EXPERIENCED A RE-OPERATIVE NECK HEMATOMA AFTER THE PARATHYROIDECTOMY. HE EXPLAINED THAT HE HAD MAYBE EXPERIENCED SOME TECHNIQUE RELATED ISSUES THAT COULD HAVE CAUSED THE HEMATOMA DUE TO INADEQUATE SEAL. ADDITIONAL INFORMATION RECEIVED THERE WERE NO DIRECT INJURIES FROM THE DEVICE. THE PATIENT DEVELOPED A POSTOPERATIVE HEMATOMA FROM BLOOD VESSELS SEALED BY THE DEVICE. THE PATIENT WAS IMMEDIATELY TAKEN TO SURGERY TO REMOVE THE HEMATOMA AND SUTURE LIGATED THE ARTERIAL BLEEDER. THE PHYSICIAN STATED THAT HE DID NOT KNOW IF THIS WAS A PROBLEM WITH THE DEVICE NOR HE COULD CONCLUSIVELY ATTRIBUTE THE POSTOP BLEEDING TO THE DEVICE. THE PHYSICIAN REPORTED THAT THEY SEALED AND DIVIDED NORMALLY, THE PATIENT HAD RETCHING AND VOMITED THEN BLEEDING OCCURRED ALMOST IMMEDIATELY AFTER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17371968 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SUPERFICIAL PAROTIDECTOMY WITH NERVE MONITORING , DURING THE PROCEDURE THE SURGEON HAD ONE BLEED AFTER A SEAL WHICH THE SURGEON DID NOT EXPECT AND HAD TO USE A BOVIE TO STOP THE BLEEDING. THEY DID NOT USE BIPOLAR FORCEPS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15573699 ↗