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N/A (REF ACE45E)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Ultrasonic Scalpel Curved Shears w/Hand Control, 15mm active blade length · Class U

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825016326), received between Jun 13, 2017 and Jun 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 13, 2017Break; Break

    IT WAS REPORTED THAT THE HARMONIC SCALPEL BROKE OFF INSIDE THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6639377 ↗

Other Scalpel, ultrasonic, reprocessed devices

All Scalpel, ultrasonic, reprocessed devices →

Sources and updates

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