Sonicision SCBA (UDI 10884521781627)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521781627), received between Jun 14, 2023 and Apr 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Cut” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 BLO OD 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 21902626 ↗
• InjuryJun 14, 2023Failure to Deliver Energy; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE FAILED TO ACTIVATE AFTER FIFTEEN MINUTES IT BEGIN TO FAIL TO ACTIVATE WITH A RED LIGHT ON THE GENERATOR. THE SURGEON ALLOWED THE TO PERFORM TESTS BY DISCONNECTING AND RECONNECTING THE ENTIRE BATTERY AND GENERATOR SYSTEM, AND THE ERROR PERSISTED. THE DEVICE KIT (BATTERY AND GENERATOR) WAS REPLACED WITHOUT SUCCESS. IN AN ATTEMPT TO CONTINUE THE PROCEDURE, A NEW DEVICE CLAMP WAS OPENED WITH THE SAME BATCH AND THE SAME PROBLEM WAS DETECTED WITH BOTH KITS USED. DUE TO WHAT HAPPENED, THE SURGEON CONVERTED THE PROCEDURE (OPEN SURGERY) TO COMPLETION. LAPAROSCOPIC TO CONVENTIONAL WAS NECESSARY BECAUSE OF A FAILURE IN THE CUTTING AND COAGULATION SYSTEM OF THE DEVICE CLEANSERS. NO PART OF THE DEVICE WAS DETACHED. THE PROCEDURE STOPPED FOR 15 MINUTES. THE PROCEDURE WAS COMPLETED VIA PRODUCT EXCHANGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Laceration(s)

  MAUDE report 17125121 ↗

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