Sonicision SCGAARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521592865), received between Oct 9, 2020 and Dec 27, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

1 FDA recall record name this device's identifier.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2021Terminated

   Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located

   Z-2240-2021 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 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 ABDOMINAL 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 21028318 ↗
• 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. NO PART OF THE DEVICE WAS DETACHED. A NEW DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED SUCCESSFULLY. 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.

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

  MAUDE report 17125189 ↗
• InjuryJun 14, 2023Failure to Deliver Energy; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Deliver Energy; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  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 17125148 ↗
• MalfunctionOct 9, 2020Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC FUNDOPLICATION, THE DEVICE DID NOT SEAL PROPERLY AND THE PATIENT BLED AND THEY WOULD NOT ABLE TO CONTROL IT WITH CLIPS AND SONICISION.

  Patient problems: No Code Available

  MAUDE report 10658005 ↗

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