Olympus WA90200ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14042761082928), received between Sep 16, 2019 and Sep 16, 2019 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUGUST 19, 2019, THE MANUFACTURER RECEIVED A MEDWATCH REPORT (# MW5088411) THAT STATES: THE PATIENT WAS ADMITTED FOR A LAPAROSCOPIC HYSTERECTOMY AS UTERINE FIBROIDS WERE IDENTIFIED PRIOR TO THE SURGERY. THE PATIENT'S UTERUS WAS DISSECTED OFF THE UTERINE WALL AND THE PK MORCELLATOR DEVICE WAS USED WITH A ZERO DEGREE LENS FOR VISUALIZATION. DURING, THE COURSE OF REMOVAL OF THE UTERUS FROM THE PNEUMOLINER CONTAINMENT BAG, PIECES OF THE PATIENT'S BOWEL WERE IDENTIFIED AND THE BOWEL WAS DAMAGED. THE USE OF THE PK MORCELLATOR WAS STOPPED AND THE PATIENT UNDERWENT A CHANGE IN PROCEDURE AS A BOWEL RESECTION WAS PERFORMED. THREE UNITS OF BLOOD WERE PROVIDED TO THE PATIENT. THE PNEUMOLINER BAG WAS FOUND TO HAVE DAMAGE AND THE MORCELLATOR CAME IN CONTACT WITH PATIENT'S SMALL BOWEL. THE PATIENT WAS DISCHARGED HOME. PER FOLLOW-UP INFORMATION, THE PATIENT IS HOME AND HAS RETURNED TO NORMAL BOWEL FUNCTION, APPROXIMATELY 20 CM OF SMALL BOWEL WAS RESECTED UNDER GENERAL SURGERY.

  Patient problems: Bowel Perforation

  MAUDE report 9071394 ↗
• InjurySep 16, 2019Break

  ON AUGUST 19, 2019, THE MANUFACTURER RECEIVED A MEDWATCH REPORT (# MW5088411) THAT STATES: THE PATIENT WAS ADMITTED FOR A LAPAROSCOPIC HYSTERECTOMY AS UTERINE FIBROIDS WERE IDENTIFIED PRIOR TO THE SURGERY. THE PATIENT'S UTERUS WAS DISSECTED OFF THE UTERINE WALL AND THE PK MORCELLATOR DEVICE WAS USED WITH A ZERO DEGREE LENS FOR VISUALIZATION. DURING, THE COURSE OF REMOVAL OF THE UTERUS FROM THE PNEUMOLINER CONTAINMENT BAG, PIECES OF THE PATIENT'S BOWEL WERE IDENTIFIED AND THE BOWEL WAS DAMAGED. THE USE OF THE PK MORCELLATOR WAS STOPPED AND THE PATIENT UNDERWENT A CHANGE IN PROCEDURE AS A BOWEL RESECTION WAS PERFORMED. THREE UNITS OF BLOOD WERE PROVIDED TO THE PATIENT. THE PNEUMOLINER BAG WAS FOUND TO HAVE DAMAGE AND THE MORCELLATOR CAME IN CONTACT WITH PATIENT'S SMALL BOWEL. THE PATIENT WAS DISCHARGED HOME. PER FOLLOW-UP INFORMATION, THE PATIENT IS HOME AND HAS RETURNED TO NORMAL BOWEL FUNCTION, APPROXIMATELY 20 CM OF SMALL BOWEL WAS RESECTED UNDER GENERAL SURGERY.

  Patient problems: Bowel Perforation

  MAUDE report 9071383 ↗