PK TECHNOLOGY PK-SP0533Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925041806), received between Aug 10, 2021 and Apr 15, 2026 — classified as 4 malfunctions.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Connection Problem

  IT WAS REPORTED THE PK SPATULA CONNECTED TO THE GENERATOR WAS NOT RECOGNIZED AND DOES NOT FUNCTION. THE ISSUE WAS FOUND DURING A THERAPEUTIC HYSTERECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888158 ↗
• MalfunctionOct 25, 2023Unintended Power Up; Unintended Power Up

  ADDITIONAL EVENT INFO. RECEIVED: THE PROCEDURE WAS A THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY AND COMPLETED USING ANOTHER SPATULA DEVICE WITHOUT IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003118 ↗
• MalfunctionMay 23, 2022Crack; Crack

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE WOULD NOT WORK WHEN IT WAS PLUGGED IN TO THE GENERATOR. THE DEVICE WAS RECOGNIZED BY THE GENERATOR, BUT AN UNKNOWN ERROR WAS DISPLAYED WHEN ATTEMPTING TO USE IT. ANOTHER DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE INTENDED PROCEDURE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, THE CUSTOMER¿S REPORTED ISSUE COULD NOT BE CONFIRMED. HOWEVER; A CRACK WAS OBSERVED IN THE CERAMIC. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING THE DEVICE EVALUATION (CRACK IN THE CERAMIC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14478355 ↗
• MalfunctionAug 10, 2021Break; Output Problem; Break; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE WHEN CONNECTED TO THE GENERATOR EXHIBITED AN ERROR MESSAGE. ACCORDING TO THE REPORT, THE ERROR MESSAGE RECEIVED WAS SIMILAR TO THE ONE WHERE THE USER HAVE TO CLEAN THE TIP OF THE DEVICE BUT DID NOT ENGAGE ON THE TISSUE YET. THE USER TRIED TO UNPLUG AND PLUG BACK AND REBOOT THE SYSTEM HOWEVER THE ISSUE WAS NOT RESOLVED. THE TYPE OF ERROR MESSAGE RECEIVED WAS NOT PROVIDED. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE FROM THE SAME LOT AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305180 ↗