Olympus A60100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761009720), received between Jul 8, 2022 and Jul 18, 2022 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING THREE DIFFERENT THERAPEUTIC LAPAROSCOPIC PROCEDURES THE INTESTINE OF THE PATIENTS WAS DAMAGED. IN THE CASE AT HAND, THE PROCEDURE WAS AN ANTERIOR RECTAL RESECTION. DURING THE PROCEDURES SEVERAL OLYMPUS INSTRUMENTS AND DEVICES FROM OTHER MANUFACTURERS WERE USED. IT CANNOT BE DETERMINED WHEN AND BY WHICH INSTRUMENT THE INTESTINE WAS PERFORATED. HOWEVER, THE PERFORATION IN THE CASE AT HAND WAS DETECTED FOUR DAYS AFTER THE INITIAL PROCEDURE WHEN THE PATIENT WAS SUBJECT TO AN ADDITIONAL SURGERY DUE TO SYMPTOMS OF PERITONITIS. ACCORDING TO THE LATEST UPDATE ALL PATIENTS ARE WELL AND THERE WAS NO REPORT ABOUT A PRODUCT MALFUNCTION.

  Patient problems: Bowel Perforation

  MAUDE report 15040315 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING THREE DIFFERENT THERAPEUTIC LAPAROSCOPIC PROCEDURES THE INTESTINE OF THE PATIENTS WAS DAMAGED. AT THE CASE AT HAND, THE PROCEDURE WAS AN ANTERIOR RECTAL RESECTION. DURING THE PROCEDURES SEVERAL OLYMPUS INSTRUMENTS AND DEVICES FROM OTHER MANUFACTURERS WERE USED. IT CANNOT BE DETERMINED WHEN AND BY WHICH INSTRUMENT THE INTESTINE WAS PERFORATED. HOWEVER, THE PERFORATION IN THE CASE AT HAND WAS DETECTED TWO DAYS AFTER THE INITIAL PROCEDURE WHEN THE PATIENT WAS SUBJECT TO AN ADDITIONAL SURGERY DUE TO SYMPTOMS OF PERITONITIS. ACCORDING TO THE LATEST UPDATE ALL PATIENTS ARE WELL AND THERE WAS NO REPORT ABOUT A PRODUCT MALFUNCTION.

  Patient problems: Bowel Perforation

  MAUDE report 15040004 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC HEMICOLECTOMY PROCEDURE THE INTESTINE OF THE PATIENT WAS DAMAGED. DURING THE PROCEDURE SEVERAL OLYMPUS INSTRUMENTS AND OTHER INSTRUMENTS WERE USED. IT CANNOT BE DETERMINED WHEN AND BY WHICH INSTRUMENT THE INTESTINE WAS PERFORATED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT A PRODUCT MALFUNCTION.

  Patient problems: Bowel Perforation

  MAUDE report 14954212 ↗