N/A (REF HAR23)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Ultrasonic Scalpel Shears without Adaptive Tissue Technology · Class U
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885825017330), received between Apr 26, 2018 and Jul 19, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Difficult to Setup or Prepare1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE TISSUE PAD FELL OFF THE HARMONIC SCALPEL (HAR23) DURING THE PROCEDURE INTO THE PATIENT. THE PAD WAS RETRIEVED BY A GRASPING DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO RETRIEVE PIECE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7703007 ↗MalfunctionApr 26, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE WHILE SETTING UP FOR THE CASE, THE TECH STATED SHE COULD NOT LOCK THE HARMONIC SCALPEL (HAR23) DEVICE TO THE HAND PIECE. THE HAND PIECE WAS CROSS THREADED. IT WAS NOTED THAT THE TECH DID NOT CONNECT THE DEVICE VERTICALLY, AS INSTRUCTED. THE PHYSICIAN CHANGED FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE, HOWEVER, THIS DECISION WAS INDEPENDENT OF AND NOT BASED ON THE DEVICE ISSUE. THE DEVICE WAS NOT REPLACED WITH ANOTHER HAR23 AS THE DEVICE WAS NO LONGER NEEDED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7465913 ↗
Other Scalpel, ultrasonic, reprocessed devices
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall94 reports
- MEDLINE HARH36RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall24 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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