Sonicision SCBA (UDI 10884521592889)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521592889), received between Oct 21, 2024 and Dec 27, 2024 — classified as 3 injuries.

2 other recalls cover devices cleared under the same FDA submission (K180149); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST TOTAL LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY WITH SENTINEL NODE BIOPSY, THE PATIENT HAD AN ABD OMINAL PAIN (ICD10-CM R10.9) AND PRESENTS FOR AN ABDOMINAL HYSTERECTOMY. THE PATIENT WAS DOING WELL POSTOPERATIVELY, THEN DEVELOPED PAIN APPROXIMATELY 2 TO 3 DAYS AFTER DISCHARGE THAT GRADUALLY GOT WORSE. THE PATIENT DENIES FEVERS OR PURULENT DISCHARGE. STATED THAT THE PATIENT HAD DECREASED APPETITE AND NAUSEA. PATIENT UNDERGONE RADIOLOGY EXAM WITH FINDINGS OF FAVOR ABSCESS ALTHOUGH SEROMA AND WALLED OFF HEMATOMA AND LARGE 10 CM LESION WITHIN THE POSTERIOR RIGHT LOBE OF THE LIVER. INTERVENTIONAL PROCEDURE PERFORMED SUCH AS FLUSH DRAIN WITH 10 CC OF SALINE EVERY 12 HOURS, MONITOR OUTPUT, FOLLOW UP CULTURES AND PARTIAL DRAINAGE OF THE FLUID COLLECTION. INTRAVENOUS (IV) ANTIBIOTICS FOLLOWED BY ORAL ANTIBIOTICS. ELECTROCARDIOGRAM (ECG) SHOWED NORMAL SINUS RHYTHM, NORMAL ECG.

  Patient problems: Abdominal Pain; Abscess; Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Appetite; Hematoma; Nausea; Pain; Seroma; Unintended Radiation Exposure

  MAUDE report 21028307 ↗
• InjuryOct 29, 2024Adverse 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 3 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 20563820 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST 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 20493289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180149. One submission often covers many models, so check the product and lot details in each record.

• Z-0332-2022 · Nov 12, 2021 · Open, Classified
  Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item
• Z-2240-2021 · Jun 23, 2021 · Terminated
  Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA