Sonicision 7 SCG7ABRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521794825), received between Mar 7, 2023 and Jul 3, 2025 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Device Difficult to Setup or Prepare; Self-Activation or Keying; Failure to Fire; Device Difficult to Setup or Prepare; Self-Activation or Keying; Failure to Fire

  ACCORDING TO THE REPORTER DURING PROCEDURE, THE DISSECTOR HAD RED LIGHT CAME ON, THEN THE SURGEON WASHED THE JAWS AND THE LIGHT WAS GREEN AGAIN. BUT THEN THE DEVICE WAS IN CONTINUOUS ACTIVATION WITHOUT TOUCHING THE BLUE ACTIVATION BUTTON AND THE TRANSDUCER WAS STUCK IN THE DEVICE, IT'S IMPOSSIBLE TO REMOVE IT. WHEN WE TURN THE TRANSDUCER WHEEL TO REMOVE IT THE ACTIVE BLADE ROTATES WITH IT. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. IT WAS NOT POSSIBLE TO USE ANOTHER DISSECTOR WITH THE SAME GENERATOR BECAUSE THE GENERATOR WAS STUCK IN THE DISSECTOR. THE DISSECTOR DID NOT BREAK. THE PROCEDURE WAS COMPLETED BY USING A NON-MEDTRONIC DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393727 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT LOBE LIVER RESECTION AND CHOLECYSTECTOMY, THE PATIENT'S VENA CAVA WAS INJURED, CAUSING MAJOR BLOOD LOSS. THE PROCEDURE INVOLVED THE USE OF THE SONICISION 7 DEVICE. THE SURGEON STARTED TRANSECTION WITH A BOVIE, GOING ~1CM DEEP. THEN USED THE SONICISION 7 TO TRANSECTION ~2-3CM DEEPER, AND FINISHED THE TRANSECTION WITH THE EGIAUSTND + 11 SIG30AVM RELOADS. THE SPECIMEN WAS REMOVED AND SENT TO PATHOLOGY TO ASSESS MARGINS. LAPS WERE PLACED AGAINST THE RESECTED LIVER AND COMPRESSION WAS HELD FOR 10 MINUTES. THE LAPS WERE REMOVED TO ASSESS THE LIVER, AND THIS IS WHEN THE SURGEON REALIZED THE HOLE IN THE VENA CAVA. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 1.5 LITERS. EFFORTS TO CONTROL HEMORRHAGE WERE INITIATED AND CODE BLUE WAS ACTIVATED. A VASCULAR SURGEON WAS CONSULTED INTRAOPERATIVELY AND SUCCESSFULLY REPAIRED THE VENA CAVA DEFECT WITH SUTURES, ACHIEVING HEMOSTASIS. THE SURGICAL SITE WAS LEFT TEMPORARILY OPEN, AND A WOUND VACUUM-ASSISTED CLOSURE (VAC) DEVICE WAS APPLIED, WITH DEFINITIVE CLOSURE COMPLETED LATER. THE WAS PATIENT WAS STABILIZED IN THE ICU POSTOPERATIVELY AND SUBSEQUENTLY DISCHARGED IN STABLE CONDITION.

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

  MAUDE report 21902562 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, THE DISSECTOR WAS USED ON A STRAIGHTFORWARD AND UNEVENTFUL LAPAROSCOPIC SLEEVE GASTRECTOMY WITH NO BLOOD LOSS. DISCHARGED HOME ON NEXT DAY AFTER NORMAL BLOOD TEST. PERFECTLY WELL UNTIL DAY 6 POSTOPERATIVELY WHEN SHE SUDDENLY COLLAPSED AT HOME. TAKEN TO LOCAL A & E, CT SCAN CONFIRMED ACTIVE BLEEDING. HAD A CRASH LAPAROTOMY AND SPLENECTOMY. TOTAL BLOOD LOSS OF THREE LITERS THAT REQUIRED BLOOD TRANSFUSION. BLEEDING WAS FROM SHORT GASTRIC VESSEL, AS FROM OP NOTES AND DISCHARGE SUMMARY. NO OTHER VASCULAR INJURIES. SPLENECTOMY WAS REQUIRED TO CONTROL BLEEDING. VESSEL WAS PREVIOUSLY DIVIDED AND SEALED WITH SONICISION DURING THE ORIGINAL SURGERY. SHE STAYED IN HOSPITAL FOR FEW DAYS AND WAS DISCHARGED HOME. PATIENT HAD SUFFERED A LIFE-THREATENING COMPLICATION WITH CATASTROPHIC BLEEDING AND ALL AVAILABLE EVIDENCE SUGGEST BLEEDING ORIGINATED FROM FAILURE OF THE DEVICE TO PROVIDE DURABLE SEALING OF THE SHORT GASTRIC VESSEL WITH PERMANENT HAEMOSTASIS. PATIENT WAS ON MEDICATION THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 21142153 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, THE DISSECTOR WAS USED ON A STRAIGHTFORWARD AND UNEVENTFUL LAPAROSCOPIC SLEEVE GASTRECTOMY WITH NO BLOOD LOSS. DISCHARGED HOME ON NEXT DAY AFTER NORMAL BLOOD TEST. PERFECTLY WELL UNTIL DAY 6 POSTOPERATIVELY WHEN SHE SUDDENLY COLLAPSED AT HOME. TAKEN TO LOCAL A, E, CT SCAN CONFIRMED ACTIVE BLEEDING. HAD A CRASH LAPAROTOMY AND SPLENECTOMY. TOTAL BLOOD LOSS OF THREE LITERS THAT REQUIRED BLOOD TRANSFUSION. BLEEDING WAS FROM SHORT GASTRIC VESSEL, AS FROM OP NOTES AND DISCHARGE SUMMARY. NO OTHER VASCULAR INJURIES. SPLENECTOMY WAS REQUIRED TO CONTROL BLEEDING. VESSEL WAS PREVIOUSLY DIVIDED AND SEALED WITH SONICISION DURING THE ORIGINAL SURGERY. SHE STAYED IN HOSPITAL FOR FEW DAYS AND WAS DISCHARGED HOME. PATIENT HAD SUFFERED A LIFE-THREATENING COMPLICATION WITH CATASTROPHIC BLEEDING AND ALL AVAILABLE EVIDENCE SUGGEST BLEEDING ORIGINATED FROM FAILURE OF THE DEVICE TO PROVIDE DURABLE SEALING OF THE SHORT GASTRIC VESSEL WITH PERMANENT HAEMOSTASIS. PATIENT WAS ON MEDICATION THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 21142084 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, THE DISSECTOR WAS USED ON A STRAIGHTFORWARD AND UNEVENTFUL LAPAROSCOPIC SLEEVE GASTRECTOMY WITH NO BLOOD LOSS. DISCHARGED HOME ON NEXT DAY AFTER NORMAL BLOOD TEST. PERFECTLY WELL UNTIL DAY 6 POSTOPERATIVELY WHEN SHE SUDDENLY COLLAPSED AT HOME. TAKEN TO LOCAL A<(>&<)>E, CT SCAN CONFIRMED ACTIVE BLEEDING. HAD A CRASH LAPAROTOMY AND SPLENECTOMY. TOTAL BLOOD LOSS OF THREE LITERS THAT REQUIRED BLOOD TRANSFUSION. BLEEDING WAS FROM SHORT GASTRIC VESSEL, AS FROM OP NOTES AND DISCHARGE SUMMARY. NO OTHER VASCULAR INJURIES. SPLENECTOMY WAS REQUIRED TO CONTROL BLEEDING. VESSEL WAS PREVIOUSLY DIVIDED AND SEALED WITH SONICISION DURING THE ORIGINAL SURGERY. SHE STAYED IN HOSPITAL FOR FEW DAYS AND WAS DISCHARGED HOME. PATIENT HAD SUFFERED A LIFE THREATENING COMPLICATION WITH CATASTROPHIC BLEEDING AND ALL AVAILABLE EVIDENCE SUGGEST BLEEDING ORIGINATED FROM FAILURE OF THE DEVICE TO PROVIDE DURABLE SEALING OF THE SHORT GASTRIC VESSEL WITH PERMANENT HAEMOSTASIS. PATIENT WAS ON MEDICATION THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 21142047 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, THE DISSECTOR WAS USED ON A STRAIGHTFORWARD AND UNEVENTFUL LAPAROSCOPIC SLEEVE GASTRECTOMY WITH NO BLOOD LOSS. DISCHARGED HOME ON NEXT DAY AFTER NORMAL BLOOD TEST. PERFECTLY WELL UNTIL DAY 6 POSTOPERATIVELY WHEN SHE SUDDENLY COLLAPSED AT HOME. TAKEN TO LOCAL A & E, CT SCAN CONFIRMED ACTIVE BLEEDING. HAD A CRASH LAPAROTOMY AND SPLENECTOMY. TOTAL BLOOD LOSS OF THREE LITERS THAT REQUIRED BLOOD TRANSFUSION. BLEEDING WAS FROM SHORT GASTRIC VESSEL, AS FROM OP NOTES AND DISCHARGE SUMMARY. NO OTHER VASCULAR INJURIES. SPLENECTOMY WAS REQUIRED TO CONTROL BLEEDING. VESSEL WAS PREVIOUSLY DIVIDED AND SEALED WITH SONICISION DURING THE ORIGINAL SURGERY. SHE STAYED IN HOSPITAL FOR FEW DAYS AND WAS DISCHARGED HOME. PATIENT HAD SUFFERED A LIFE-THREATENING COMPLICATION WITH CATASTROPHIC BLEEDING AND ALL AVAILABLE EVIDENCE SUGGEST BLEEDING ORIGINATED FROM FAILURE OF THE DEVICE TO PROVIDE DURABLE SEALING OF THE SHORT GASTRIC VESSEL WITH PERMANENT HAEMOSTASIS. PATIENT WAS ON MEDICATION THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 21142010 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, THE DISSECTOR WAS USED ON A STRAIGHTFORWARD AND UNEVENTFUL LAPAROSCOPIC SLEEVE GASTRECTOMY WITH NO BLOOD LOSS. DISCHARGED HOME ON NEXT DAY AFTER NORMAL BLOOD TEST. PERFECTLY WELL UNTIL DAY 6 POSTOPERATIVELY WHEN SHE SUDDENLY COLLAPSED AT HOME. TAKEN TO LOCAL A, E, CT SCAN CONFIRMED ACTIVE BLEEDING. HAD A CRASH LAPAROTOMY AND SPLENECTOMY. TOTAL BLOOD LOSS OF THREE LITERS THAT REQUIRED BLOOD TRANSFUSION. BLEEDING WAS FROM SHORT GASTRIC VESSEL, AS FROM OP NOTES AND DISCHARGE SUMMARY. NO OTHER VASCULAR INJURIES. SPLENECTOMY WAS REQUIRED TO CONTROL BLEEDING. VESSEL WAS PREVIOUSLY DIVIDED AND SEALED WITH SONICISION DURING THE ORIGINAL SURGERY. SHE STAYED IN HOSPITAL FOR FEW DAYS AND WAS DISCHARGED HOME. PATIENT HAD SUFFERED A LIFE-THREATENING COMPLICATION WITH CATASTROPHIC BLEEDING AND ALL AVAILABLE EVIDENCE SUGGEST BLEEDING ORIGINATED FROM FAILURE OF THE DEVICE TO PROVIDE DURABLE SEALING OF THE SHORT GASTRIC VESSEL WITH PERMANENT HAEMOSTASIS. PATIENT WAS ON MEDICATION THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 21141975 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, THE DISSECTOR WAS USED ON A STRAIGHTFORWARD AND UNEVENTFUL LAPAROSCOPIC SLEEVE GASTRECTOMY WITH NO BLOOD LOSS. DISCHARGED HOME ON NEXT DAY AFTER NORMAL BLOOD TEST. PERFECTLY WELL UNTIL DAY 6 POSTOPERATIVELY WHEN SHE SUDDENLY COLLAPSED AT HOME. TAKEN TO LOCAL A & E, CT SCAN CONFIRMED ACTIVE BLEEDING. HAD A CRASH LAPAROTOMY AND SPLENECTOMY. TOTAL BLOOD LOSS OF THREE LITERS THAT REQUIRED BLOOD TRANSFUSION. BLEEDING WAS FROM SHORT GASTRIC VESSEL, AS FROM OP NOTES AND DISCHARGE SUMMARY. NO OTHER VASCULAR INJURIES. SPLENECTOMY WAS REQUIRED TO CONTROL BLEEDING. VESSEL WAS PREVIOUSLY DIVIDED AND SEALED WITH SONICISION DURING THE ORIGINAL SURGERY. SHE STAYED IN HOSPITAL FOR FEW DAYS AND WAS DISCHARGED HOME. PATIENT HAD SUFFERED A LIFE-THREATENING COMPLICATION WITH CATASTROPHIC BLEEDING AND ALL AVAILABLE EVIDENCE SUGGEST BLEEDING ORIGINATED FROM FAILURE OF THE DEVICE TO PROVIDE DURABLE SEALING OF THE SHORT GASTRIC VESSEL WITH PERMANENT HAEMOSTASIS. PATIENT WAS ON MEDICATION THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 21141917 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OOPHORECTOMY WITH SALPINGECTOMY, THE PATIENT HAD A 2CM BURN DEFECT IN BLADDER AND IT WAS REPAIRED. DURING THE OPERATION, CYSTOSCOPY WAS PERFORMED AND BLOOD WAS SEEN IN FOLEY CATHETER. FOLEY CATHETER WAS REMOVED AND SPONTANEOUSLY VOIDED PRIOR TO DISCHARGE. URINE OUTPUT WAS 1500CC OVERNIGHT AND MINIMAL BLOOD WAS NOTED. CREATININE WAS 0.7 AND STABLE. ON THE NEXT DAY, THE PATIENT REPORTED DECREASED URINE OUTPUT, ABDOMINAL PAIN, SWELLING AND DYSURIA. PATIENT HAD PROLONGED HOSPITALIZATION. FOLEY CATHETER WAS PLACED DURING IN-OFFICE VISIT AND 500CC OUTPUT IMMEDIATELY ON PLACEMENT. FOLEY CATHETER REMAINED FOR FEW DAYS. FOLEY CATHETER WAS REMOVED. URINE SPECIMEN WAS COLLECTED FOR CULTURE AND SENSITIVITY. EXTENSIVE VESICOUTERINE FIBROSIS WAS PRESENT PRIOR TO SURGERY AND HOLE IN THE BLADDER WAS A RESULT OF THE ABNORMAL ANATOMY AND NOT CAUSED BY INSTRUMENT. PATIENT IS WELL.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Dysuria; Hematuria; Swelling/ Edema

  MAUDE report 20493214 ↗
• MalfunctionMay 22, 2024Device Difficult to Setup or Prepare; Self-Activation or Keying; Device Difficult to Setup or Prepare; Self-Activation or Keying

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE DEVICE¿S OUTPUT CONTINUED EVEN THOUGH THE OUTPUT BUTTON WAS NOT PRESSED. WHEN THE OUTPUT BUTTON WAS PRESSED, IT STOPPED. IT WAS USED AFTERWARDS BUT SAME MANNER EVEN THOUGH THE OUTPUT BUTTON WAS NOT PRESSED, IT CONTINUED TO OUTPUT. WHEN THE OUTPUT BUTTON WAS PRESSED, THE RED LIGHT LIT UP. RE-SETUP WAS ATTEMPTED BUT THE GENERATOR RUN IDLE FROM THE DEVICE AND COULD NOT BE REMOVED. A NEW SET WAS TAKEN OUT AND DEALT WITH IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371309 ↗
• MalfunctionSep 5, 2023Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THROUGHOUT THE CASE, THE GENERATOR WAS HISSING SLIGHTLY. SEALING WAS OKAY UNTIL THE LAST VESSEL, THERE WAS A SLIGHT BLEED (LESS THAN 500CC) BUT THEN SEEMED TO SEAL OKAY AFTER THAT SO SURGEON CONTINUED USING THE DEVICE. PATIENT WAS FINE AND WENT HOME AS PLANNED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17685892 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2023 DAY 2 OF POST-OPERATIVE SLEEVE GASTRECTOMY, PATIENT HAD A MAJOR ARTERIAL BLEEDING 5-600CC AND WAS TAKEN BACK TO THE OR TO DO ADDITIONAL LAPAROSCOPIC PROCEDURE AND WAS ADMITTED TO ICU. THIS EVENT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. PATIENT BECAME HYPOTENSIVE AND SYNCOPATIC. PATIENT WAS GIVEN TRANEXAMIC ACID, THERE WAS NO OBVIOUS BLEEDING WHEN SURGEON WENT BACK IN, AND USED ONE OF THE SEALING PRODUCTS AND SPRAYED OVER THE PRESUMED AREA. SURGEON EVALUATED THE CLOT AND IT WAS ON THE OMENTUM SIDE NEAR THE SHORT GASTRIC VESSELS. PATIENT HEMOGLOBIN DROPPED TO ABOUT 8, COAGS WERE NORMAL, AND ALL THE OTHERLABS WERE NORMAL. PATIENT WAS GIVEN 4 UNIT OF BLOODS. PATIENT RECEIVED POST-OPERATIVE MEDICINES SUCH AS: OMEPRAZOLE, ANTIBIOTICS, FENTANYL, HEPARIN AND ONDANSETRON FOR NAUSEA. PATIENT WAS ON HEPARIN WHICH WAS STANDARD. PATIENT HAS NOW RECOVERED AND NO ILL EFFECTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 16530080 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON (B)(6) 2023 DAY 2 OF POST-OPERATIVE SLEEVE GASTRECTOMY, PATIENT HAD A MAJOR ARTERIAL BLEEDING 5-600CC AND WAS TAKEN BACK TO THE OR TO DO ADDITIONAL LAPAROSCOPIC PROCEDURE AND WAS ADMITTED TO ICU. THIS EVENT LED TO OR EXTEND PATIENT HOSPITALIZATION. PATIENT BECAME HYPOTENSIVE AND SYNCOPATIC. PATIENT WAS GIVEN TRANEXAMIC ACID, AND THERE WAS NO OBVIOUS BLEEDING WHEN SURGEON WENT BACK IN, AND USED ONE OF THE SEALING PRODUCTS AND SPRAYED OVER THE PRESUMED AREA. SURGEON EVALUATED THE CLOT AND IT WAS ON THE OMENTUM SIDE NEAR THE SHORT GASTRIC VESSELS. PATIENT¿S HEMOGLOBIN DROPPED TO ABOUT 8, COAGS WERE NORMAL, AND ALL THE OTHER LABS WERE NORMAL. PATIENT WAS GIVEN 4 UNIT OF BLOODS. PATIENT RECEIVED POST-OPERATIVE MEDICINES SUCH AS: OMEPRAZOLE, ANTIBIOTICS, FENTANYL, HEPARIN AND ONDANSETRON FOR NAUSEA. PATIENT WAS ON HEPARIN WHICH WAS STANDARD. PATIENT HAS NOW RECOVERED AND NO ILL E FFECTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 16529984 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE GENERATOR HAD AN ISSUE. THE PATIENT WAS REQUIRED A BLOOD TRANSFUSION AND WAS RETURNED TO OR. THE PATIENT HAS NOW RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16499983 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE GENERATOR HAD AN ISSUE. THE PATIENT WAS REQUIRED A BLOOD TRANSFUSION AND WAS RETURNED TO OR. THE PATIENT HAS NOW RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16499643 ↗