Olympus WB990207Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761085014), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Component Falling” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2018Component Falling; Component Falling

  OLYMPUS WAS INFORMED THAT AFTER AN RF VNUS PROCEDURE, THE PROTECTIVE COVERING OF THE DEVICE WAS OBSERVED INSIDE THE PATIENT. AFTER THE PROCEDURE, THE DOCTOR PERFORMED AN ULTRASOUND ON THE PATIENT AND OBSERVED SOMETHING ABNORMAL IN THE PATIENT'S LEG. THE PATIENT WAS RUSHED TO A LOCAL HOSPITAL AND A CT SCAN WAS PERFORMED, HOWEVER, THERE WAS FOREIGN OBJECT FOUND. THE PATIENT WAS THEN BROUGHT BACK TO THE USER FACILITY FROM WHICH THE DOCTOR CONFIRMED THE FOREIGN OBJECT WHICH SLIGHTLY REGRESSED IN THE PATIENT'S RIGHT LEG. THE OLYMPUS SALES REPRESENTATIVE ASKED THE DOCTOR IF HE HAD REMOVED THE PROTECTIVE COVERING FROM THE DEVICE WHICH THE DOCTOR CONFIRMED THAT HE DID NOT REMOVE THE PROTECTIVE COVERING PRIOR TO PROCEDURE. THE PATIENT WAS THEN PUT UNDER LOCAL ANESTHESIA AND A SURGICAL INTERVENTION WAS PERFORMED. THE PROTECTIVE COVERING WAS REMOVED FROM THE PATIENT¿S LEG SUCCESSFULLY. THE PATIENT RECOVERED AND WAS DISCHARGED ON THE SAME DAY. THE PATIENT WAS REPORTED TO BE DOING FINE AND IS SCHEDULED FOR A FOLLOW UP AT A LATER DATE. ADDITIONALLY, THE DOCTOR USED A FIRST DEVICE AND THE MACHINE WAS NOT TURNING THE DEVICE ON. A SECOND DEVICE WAS USED AND THE SAME THING OCCURRED. A 3RD KIT WAS US

  Patient problems: Foreign Body In Patient

  MAUDE report 7657990 ↗