N/A (REF FCS9)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Ultrasonic Scalpel Curved Shears with Torque Wrench/Grip Assis, 16mm blade length · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825016012), received between Feb 22, 2017 and Feb 22, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
Device problems
- Insufficient Device Problem Information1
Patient problems
- Abscess1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2017Insufficient Device Problem Information
IT WAS REPORTED THAT A HARMONIC FOCUS WAS USED DURING A HEMITHYROIDECTOMY. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND UPON DISCHARGE THE PATIENT WAS NOT PRESCRIBED ANTIBIOTICS. FIVE DAYS POST-PROCEDURE THE PATIENT DEVELOPED AN INFECTION AND WAS ADMITTED WITH A LARGE ABSCESS AT THE SURGICAL SITE WHICH REQUIRED IMMEDIATE INCISION AND DRAINAGE. THE PATIENT SPENT TIME INTUBATED IN CRITICAL CARE AND EXPERIENCED JAW PROBLEMS THAT SHE RELATES TO BEING INTUBATED FOR SEVERAL DAYS. THERE WAS NO PERMANENT IMPAIRMENT OR DAMAGE REPORTED AND THE PATIENT'S MEDICAL CONDITION HAS SINCE IMPROVED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 6351295 ↗
Other Scalpel, ultrasonic, reprocessed devices
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall94 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall24 reports
- MEDLINE HARH36RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall24 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed67 reports
- Medline HARH45RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall2 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 death31 reports
- N/A HAR1136Stryker Sustainability Solutions, Inc. · Single-use reprocessed ultrasonic surgical instruments24 reports
- Medline HAR36MRMedline Industries, Inc. · Scalpel, ultrasonic, reprocessed16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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