FASTSEAL 6.0 HEMOSTASIS WAND 72290042Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556787229), received between Feb 11, 2022 and Sep 19, 2025 — classified as 1 death, 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Arcing” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A HIP PROSTHESIS SURGERY, IT WAS NOTICED THAT THE ELECTRODE OF THE WEREWOLF FAST SEAL WAND HAS TURNED THE TISSUE BLACK/CARBONACEOUS APPROXIMATELY 5 MINUTES INTO THE OPERATION. THERE WAS NO BURNS AS THE BLACK TISSUE WAS LIKE WITH THE MONOPOLAR WHEN WORKING AT A MUCH HIGHER TEMPERATURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23095972 ↗
• MalfunctionSep 26, 2024Self-Activation or Keying; Arcing; Self-Activation or Keying; Arcing

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WEREWOLF FASTSEAL WAND SPARKED AND WOULD NOT POWER DOWN, WHICH MEANT THAT THE DEVICE WAS PRODUCING PLASMA WITHOUT BEING ACTIVATED. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313085 ↗
• MalfunctionSep 6, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING A HIP PROCEDURE, THE WEREWOLF FASTSEAL WOULD TURN ON AND NOT TURN OFF. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163942 ↗
• MalfunctionAug 29, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT, DURING A HIP PROCEDURE, THE WEREWOLF FASTSEAL WOULD TURN ON AND NOT TURN OFF. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20096687 ↗
• MalfunctionDec 22, 2023Failure to Shut Off; Key or Button Unresponsive/not Working; Failure to Shut Off; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE WEREWOLF FASTSEAL STAYED ON EVEN THOUGH IT WAS NOT BEING USED, AND WAS SMOKING AS IT EVAPORATED THE SALINE IN MID AIR. THE MACHINE DISPLAYED AN ERROR CODE STATING THAT TOO MANY BUTTONS HAD BEEN PUSHED SIMULTANEOUSLY. NO ADDITIONAL INFORMATION REGARDING THE ERROR CODE IS AVAILABLE AND NO DAMAGE WAS CAUSED DUE TO THE CONTINUOUSLY ACTIVATED DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TWO MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18385295 ↗
• DeathAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SURGERY FOR AN ANTERIOR HIP WITH A FASTSEAL DEVICE WITH NO COMPLICATIONS, PATIENT CONSENTED FOR PARTICIPATION ON (B)(6) 2023 WITH BENIGN POST OP COURSE. STARTING ON THE WEEKEND OF THE (B)(6) 2023, PATIENT WAS ADMITTED FOR LIKELY ILEUS ALONG WITH REPORTED WAXING/WANING ALTERED MENTAL STATUS ON THIS DAY. HE QUICKLY DECOMPENSATED OVER THE FOLLOWING 24-48 HOURS REQUIRING INCREASE IN RESPIRATORY SUPPORT AND CV SUPPORT AND ULTIMATELY RESULTED IN HIS DEATH ON (B)(6) 2023. THE SURGICAL TEAM EVALUATED THE PATIENT WITH NO CONCERNS ON THE RIGHT HIP, THEY CONSIDERED HE WAS A RESEARCH PATIENT AND DEEMED THAT THIS WAS A SEVERE ADVERSE EVENT RESULTING IN DEATH OF THE PATIENT/PARTICIPANT, BUT WAS CONSIDERED UNRELATED TO THE STUDY DEVICE.

  Patient problems: Obstruction/Occlusion; Unspecified Gastrointestinal Problem; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 17611946 ↗
• MalfunctionJun 15, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING SET UP, THE SURGEON WAS HOLDING THE WEREWOLF FASTSEAL HEMOSTASIS WAND AND NOT ENGAGING THE BUTTON, AND A LOUD POP AND AN ARC OF CURRENT CAME FROM THE TIP OF THE WAND. IT IS UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134323 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL ACTIVITY REVIEW FASTSEAL MAP 1009, 1 PATIENT HAD A QUAD TEAR AFTER A TKA PROCEDURE USING A FASTSEAL WAND. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 16967894 ↗
• MalfunctionMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL ACTIVITY REVIEW FASTSEAL MAP 1009, 1 PATIENT HAD A KNEE HEMATOMA, JOINT INFECTION AND REQUIRED A WOUND VAC AFTER A TKA PROCEDURE USING A FASTSEAL WAND. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 16963873 ↗
• MalfunctionMay 18, 2023Noise, Audible

  SURGEON HAD THE WEREWOLF IN HIS RIGHT HAND, NOT ENGAGING THE BUTTONS, AND A LOUD POP AND AN ARC OF CURRENT CAME FROM THE TIPS OF THE WEREWOLF. AT NO POINT HAD THE SURGEON ENGAGED THE CURRENT BUTTONS. HE STATED THIS HAD HAPPENED AT ANOTHER BAPTIST FACILITY DURING THE TRIAL. THIS DEVICE/PRODUCT IS NOT SAFE FOR USE IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963067 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL ACTIVITY REVIEW FASTSEAL MAP 1009, 1 PATIENT HAD A QUAD DISRUPTION AFTER A TKA PROCEDURE USING A FASTSEAL WAND. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 16954940 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL ACTIVITY REVIEW FASTSEAL MAP 1009, 1 PATIENT HAD A QUAD TENDON RUPTURE AFTER A TKA PROCEDURE USING A FASTSEAL WAND. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 16949071 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL ACTIVITY REVIEW FASTSEAL MAP 1009, 1 PATIENT HAD A QUAD TENDON RUPTURE DUE TO A FALL AFTER A TKA PROCEDURE USING A FASTSEAL WAND. IT IS UNKNOWN HOW WAS THE EVENT TREATED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 16941152 ↗
• MalfunctionNov 8, 2022Smoking; Failure to Shut Off; Smoking; Failure to Shut Off

  IT WAS REPORTED THAT DURING AN THA SURGERY, THE DOCTOR WAS USING A FASTSEAL INSIDE THE JOINT AND WHEN HE STOPPED PRESSING THE BUTTON THE DEVICE WAS STILL GOING, SPEWING FLUID AND SMOKE FOR 45 SECONDS OUTSIDE THE JOINT BEFORE STOPPING ON ITS OWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755022 ↗
• MalfunctionMay 5, 2022Output Problem

  THE WEREWOLF FASTSEAL 6.0 HEMOSTASIS WAND STOPS WHILE WORKING. IT TAKES MULTIPLE PRESSES ON THE HAND PIECE TO MAKE WORK. HEALTH CARE PROVIDER HAS PULLED OFF THE SHELF ALL THE SAME LOT NUMBER FOR THE TIME BEING.

  Patient problems: Insufficient Information

  MAUDE report 14287875 ↗
• MalfunctionFeb 11, 2022Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE WEREWOLF FASTSEAL WAND KEPT CUTTING OFF WHEN THE BUTTON WAS BEING PRESSED BUT IT ALSO CONTINUALLY RUN IF IT WAS HELD UPSIDE DOWN WITHOUT BEING PRESSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518121 ↗