BiZact BZ4212ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521723016), received between Feb 8, 2018 and Sep 2, 2025 — classified as 1 death, 20 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (7 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Energy Output Problem; Failure to Cut; Intermittent Energy Output; Energy Output Problem; Failure to Cut; Intermittent Energy Output

  IT WAS REPORTED THAT DURING AN OPEN TONSILLECTOMY PROCEDURE; THE DEVICE WAS APPLIED TO THE TONSILS AND EXHIBITED INADEQUATE OR PARTIAL SEALING AND CUTTING ON NORMAL THICKNESS OF TISSUE. THE DEVICE GAVE A SEALING SOUND BUT DID NOT GIVE THE SEAL COMPLETE TONE AND WITH EVIDENCE OF ENERGY DELIVERY. ANOTHER DEVICE WAS SUBSEQUENTLY USED SUCCESSFULLY. PATIENT HAD MINOR BLEEDING AFTER CUTTING AND BLOOD TRANSFUSION WAS NOT NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22937355 ↗
• DeathJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-TONSILLECTOMY PROCEDURE AND FROM AN ADDITIONAL INFORMATION, IT WAS FOUND OUT THAT THE SURGEON HAS USED THE BIZACT DEVICE FOR ABOUT SIX WEEKS. IN THAT TIME, HE HAD THREE BLEEDS. ONE WAS IMMEDIATELY POST-OP THAT HE STOPPED WITH CAUTERY, ONE WITH NO ADDITIONAL DETAIL, AND A PEDIATRIC PATIENT THAT RETURNED AFTER FIVE DAYS TO THE HOSPITAL WITH EXCESSIVE POST-OP BLEEDING AND EVENTUALLY PASSED AWAY DUE TO BLOOD LOSS. A FORCETRIAD WAS USED TOGETHER WITH THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19721361 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT. PHOTO RECEIVED SHOWED THAT THE DEVICE HAD DAMAGED INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843122 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843112 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843109 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843080 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Device Damaged Prior to Use; Peeled/Delaminated; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, PRIOR TO USE, FIVE BIZACT DEVICES HAD BROKEN TIPS IN THE PACKAGE WHICH WAS NOT VISIBLE ON FOUR OF THE DEVICES UNTIL THE PACKAGE WAS OPENED. FOUR DEVICES WITH LOT# 32980227X, AND ONE BROKEN DEVICE WITH LOT# 32770247X. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843076 ↗
• InjuryMay 25, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A POST-OP BLEED AFTER A TONSILLECTOMY DURING A BIZACT TRIAL. HEMOSTASIS WAS ACHIEVED DURING THE PROCEDURE. EVENT OCCURRED ONE DAY AFTER THE SURGERY. WHICH LED TO RE-ADMITTANCE INTO OPERATING ROOM AND EXTENT OF HOSPITALIZATION FOR FEW DAYS. DURING PROCEDURE AN ACTIVATION WAS HEARD, NO RE-GRASP ALERT, AN END-TONE AND ENERGY DELIVERY WAS OBSERVED. PATIENT'S HEALTH HAS IMPROVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17002033 ↗
• InjuryMay 19, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS BROUGHT BACK TO MANAGE A TONSILLECTOMY BLEEDING. THE EVENT EXTEND PATIENT'S HOSPITALIZATION TO ONE DAY. NO TRANSFUSION WAS REQUIRED. RE-OPERATION OR ADDITIONAL SURGICAL PROCEDURES WAS NEEDED. NO ISSUE DURING INTRA-OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14435808 ↗
• MalfunctionMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF TONSILLECTOMY, THE PATIENT HAD SEVERE SWELLING OF THE UVULA. THE PATIENT HAD MASSIVE TONSILLAR HYPERTROPHY AND A SMALL UVULA. THE LYMPHATIC DRAINAGE WAS SEALED OFF DURING USED OF THE DEVICE RESULTING IN UVULAR SWELLING.

  Patient problems: Swelling/ Edema

  MAUDE report 11764344 ↗
• MalfunctionMar 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE NEEDS TO TEST FOR NORMAL OPERATION. THE PATIENT HAD BURNS ON THE RIGHT SIDE OF THE MOUTH.

  Patient problems: Burn(s)

  MAUDE report 9772706 ↗
• InjuryOct 2, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD BLEEDING AND WENT TO RURAL EMERGENCY DEPARTMENT WHERE THE PATIENT TURNED AWAY AND DID NOT GET LABORATORY. THE PATIENT PRESENTED IN EMERGENCY DEPARTMENT AGAIN AND STILL DID NOT HAVE LABORATORY DONE AND WAS SENT HOME AFTER 4 HOURS OBSERVATION. THE PATIENT CONTINUED TO HAVE INTERMITTENT BLEEDING AT HOME AND WENT TO HOSPITAL THE NEXT DAY. PATIENT'S HEMOGLOBIN WAS LOW AT THAT POINT IT NEEDED A BLOOD TRANSFUSION. SURGEON STATED THAT THERE WAS NOT AN ARTERIAL BLEED BUT IT WAS VENOUS OOZING ALL WEEKEND. PATIENT HAD TO BE TAKEN TO OPERATING ROOM AND CAUTERIZED TO STOP BLEEDING AND HAD TO BE TRANSFUSED BECAUSE OF A LOT OF BLOOD LOSS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9149335 ↗
• InjurySep 19, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THREE DAYS AFTER TONSILLECTOMY, THE DEVICE HAD INADEQUATELY SEALED THE INFERIOR POLE OF LEFT TONSIL BED. REOPERATION WAS INITIATED TO COAGULATE THE TONSIL BED. THE PATIENT HAD 1000 CUBIC CENTIMETERS (CC) OF BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT WAS SENT HOME STABLE WITH NO ACTIVE BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9090446 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOUR DAYS POST-OPERATIVELY, THE PATIENT HAD INCURRED A TONSIL BLEED ON THE RIGHT SIDE MID-FOSA AREA. BLEEDING WAS AT LEAST 250 CC AND REQUIRED NO TRANSFUSION. THE PATIENT WAS SENT BACK TO THE OPERATING ROOM FOR CONTROL OF BLEEDING. THE PATIENT WAS ON POST-OP MEDICATIONS STARTED ON DAY ONE.

  Patient problems: Blood Loss

  MAUDE report 8767674 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO BE BROUGHT BACK IN THE OR TO CONTROL THE 10 DAY POST OPERATIVE ARTERIAL BLEEDING ON THE RIGHT INFERIOR POLE. THE PATIENT HAD UNDERGONE TONSILLECTOMY AND ADENOIDECTOMY AND WAS TAKING PAIN MEDICATIONS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8723675 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE SURGEON WAS TREATING A PATIENT WHO WAS 13 DAY POST TONSILLECTOMY AND A SUCTION BOVIE WAS USED FOR THE TREATMENT. THE PATIENT WAS ABLE TO EAT NORMAL FOOD AND ACTED NORMAL FOR A WEEK AND NOW HAD A POST-OPERATIVE BLEEDING. THE SOURCE OF BLEEDING WAS UNDERNEATH THE RIGHT SIDE ANTERIOR PILLAR OF THE PATIENT. THE TOTAL BLOOD LOSS AT HOME AND IN THE OPERATING ROOM TO TREAT THE BLEED WAS ESTIMATED AT 100 CC BY THE SURGEON AND NO BLOOD TRANSFUSION WAS NEEDED. THE PATIENT'S CURRENT STATUS IS GOOD.

  Patient problems: Blood Loss

  MAUDE report 8471826 ↗
• InjuryMar 29, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING POST-OP TONSILLECTOMY, THE PATIENT PRESENTED BACK TO PHYSICIAN WITH POST-OP BLEEDING ESTIMATED 200ML THAT REQUIRED SURGICAL INTERVENTION. THE PRIMARY SURGERY WAS DONE. TONSIL BLEEDING ATTEMPTED TO BE CONTROLLED CONSERVATIVELY WITH ICE WATER RINSES AT HOME AND IN THE ER. BLEEDING STOPPED AND PATIENT WAS SENT HOME BUT BLEEDING RECURRED AND HE WAS TAKEN TO THE OPERATING ROOM (OR) FOR CAUTERY OF THE TONSIL FOSSA. THE PATIENT WAS SENT HOME AFTER CAUTERIZATION OF BLEEDING SITE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8464947 ↗
• InjuryMar 1, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, SEVERAL DAYS AFTER THE PROCEDURE, THE SURGEON NOTED THAT THE PATIENT HAD SOME POST OP BLEEDING. PATIENT WAS READMITTED TO HOSPITAL FOR CONTROL OF BLEEDING.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8381772 ↗
• MalfunctionFeb 28, 2019Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN THE SURGEON PULLS THE TRIGGER IT GETS SORT OF STUCK AND WHEN SHE RELEASES THE LARGER HANDLE THE BLADE TRIGGER WILL THEN RELEASE, BUT THIS IS NOT HOW IT IS DESIGNED. CASE WAS CONTINUED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378046 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT HAD POST-OP BLEEDING AND WAS BROUGHT BACK IN THE OR TO CONTROL THE BLEEDING. THE SURGEON CONTROLLED IT WITH BOVIE CAUTERY ON POST-OP DAY 11 AND CURRENTLY DOING WELL.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8224182 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 2-DAYS POST OPERATIVELY, THE PATIENT WAS VOMITING BLOOD. THE PHYSICIAN EXAMINED THE PATIENT AND FOUND NO SIGNS OF ACTIVE BLEEDING; ALSO THE TONSIL BEDS LOOKED GOOD/NORMAL AND NO BLOOD CLOTS COULD BE SEEN. THE PHYSICIAN IS NOT SURE WHERE THE BLEEDING CAME FROM. A SUCTION BOVIE WAS USED FOR THE ADENOIDECTOMY BUT NO OTHER DEVICE WAS USED IN THE TONSILLECTOMY PART OF THE PROCEDURE. THE PATIENT WAS SEEN BY THE DOCTOR, BUT NO SURGICAL INTERVENTION WAS NEEDED BECAUSE THE PATIENT WAS NOT ACTIVELY BLEEDING NOR COULD A SOURCE OF THE BLEEDING BE SEEN OR DETERMINED AT THE TIME. PATIENT CAME IN TO BE SEEN BECAUSE OF REPORTED VOMITING BLOOD.

  Patient problems: Blood Loss

  MAUDE report 8133634 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD POST-OPERATIVE BLEEDING 3 DAYS AFTER A BIZACT TONSILLECTOMY. PATIENT CAME TO THE OFFICE OF AN ON CALL SURGEON AND CLOT WAS REMOVED FROM THE SUPERIOR POLE OF LEFT. NO ACTIVE BLEEDING AT THAT TIME. HE HAD STARTED IBUPROFEN. THE DOCTOR USED SILVER NITRATE ON THE AREA.

  Patient problems: Blood Loss

  MAUDE report 7841610 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A BIZACT TONSILLECTOMY, THE PATIENT HAD TO BE TREATED WITH FLUIDS IN THE ER AND SENT HOME.

  Patient problems: Dehydration; No Code Available

  MAUDE report 7735500 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A BIZACT TONSILLECTOMY, THE PATIENT HAD TO BE TAKEN TO THE OPERATING ROOM FIVE DAYS AFTER THE SURGERY TO CONTROL THE BLEEDING. THEY CAUTERIZED WITH A SUCTION BOVIE.

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

  MAUDE report 7723778 ↗
• MalfunctionJun 22, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A TONSILLECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT/IMPOSSIBLE TO OPEN. THE JAWS KEPT STICKING TOGETHER IN CLOSED POSITION AFTER ACTIVATION WHEN DOING THE LEFT TONSIL (SECOND SIDE). THERE WAS SLIGHTLY MORE BLOOD LOSS ON THE LEFT SIDE TONSIL THAN THE RIGHT SIDE. THE SURGEON WAS USING THE DEVICE CORRECTLY AND CLEANED THE INSTRUMENT SEVERAL TIMES. REPLACED WITH A NEW ONE AND IT WORKED MUCH BETTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629672 ↗