OASYS 48561051Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327271492), received between Jun 13, 2016 and Jun 13, 2016 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2016Use of Device Problem; Incorrect Device Or Component Shipped; Use of Device Problem

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN CANADIAN KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721524 ↗
• MalfunctionJun 13, 2016Use of Device Problem; Incorrect Device Or Component Shipped; Use of Device Problem

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN (B)(4) KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721519 ↗
• MalfunctionJun 13, 2016Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN CANADIAN KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721477 ↗
• MalfunctionJun 13, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN CANADIAN KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721472 ↗
• MalfunctionJun 13, 2016Use of Device Problem; Device Markings/Labelling Problem; Use of Device Problem

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN CANADIAN KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721471 ↗
• MalfunctionJun 13, 2016Use of Device Problem; Incorrect Device Or Component Shipped; Use of Device Problem

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN CANADIAN KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721468 ↗
• MalfunctionJun 13, 2016Use of Device Problem; Device Markings/Labelling Problem; Use of Device Problem

  IT WAS REPORTED THAT A SINGLE-USE INSTRUMENT EXISTS IN CANADIAN KITS AS A REUSABLE ITEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5721467 ↗