Sheath Section MAJ-655Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170062445), received between Feb 4, 2021 and Feb 7, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (20 reports).

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

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(4) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 20TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290685 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6), 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 19TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290678 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 18TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290677 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 17TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290672 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 16TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290667 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 15TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290662 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 14TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290660 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 13TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290658 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 12TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290650 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 11TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290649 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 10TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290645 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 9TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290643 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 8TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290642 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 7TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290641 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 6TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290640 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 5TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290636 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 4TH ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290630 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 13, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE 3RD ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290629 ↗
• MalfunctionFeb 7, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6), 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE SECOND ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11290616 ↗
• MalfunctionFeb 4, 2021Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE USER HAS NOT BEEN FOLLOWING THE IFU REPROCESSING METHODS. 20 DEVICES WERE AFFECTED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) JUDGED THAT THE REPORTED EVENT WAS REPORTABLE. THIS IS THE FIRST ONE OF TWENTY REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11277496 ↗