Oasis G25380Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002253803), received between Nov 13, 2019 and Oct 29, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  DESCRIPTION OF EVENT IMPOSSIBLE TO JETTISON THE PROSTHESIS AS PER CC FORM". UNABLE TO REMOVE THE STENT FROM THE ENDOSCOPE , THEY REMOVED THE PATIENT'S ENDOSCOPE AND REMOVED THE STENT STUCK AND THEN PUT ANOTHER BOSTON SCIENTIFIC BRAND STENT. PATIENT/EVENT INFO - NOTES 1. WHAT WAS THE TARGET LOCATION FOR THE STENT? BILE DUCT 3. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. NORMAL 4. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE?* BRAND PIOLAX DIAMETER 0,35¿¿ 5. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES 6. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES 7. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES 8. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? SPHINCTEROTOMY 9. IF YES, PLEASE INDICATE THE TYPE OF PROCEDURE PERFORMED. SPHINCTEROTOMY. 10. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED?* ANOTHER STENT ( BOSTON SCIENTIFIC BRAND) 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413814 ↗
• MalfunctionFeb 10, 2020Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9685903 ↗
• InjuryNov 21, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  COMPLAINT RECEIVED FROM DM VIA E-MAIL ON 05NOV2019--DID 05NOV2019. AS REPORTED TO CUSTOMER RELATIONS: "I RECEIVED A PRODUCT COMPLAINT ON 10/25 REGARDING OUR STENT INTRODUCER IN RELATION TO A BILIARY PROCEDURE. CUSTOMER: THE (B)(6) HOSPITAL, (B)(6). CONTACT: (B)(6), LPN (LEAD ENDOSCOPY TECHNICIAN). GPN: G25380, LOT C1629388. DESCRIPTION: DURING AN ERCP, THE ENDOSCOPIST AND TECHNICIAN USED A STENT INTRODUCER TO ADVANCE A PLASTIC BILIARY STENT INTO THE WORKING CHANNEL OF A DUODENOSCOPE. UNKNOWINGLY, THE STENT INTRODUCER WAS ADVANCED BEYOND THE BIOPSY PORT AND INTO THE SCOPE. BECAUSE THE TEAM WERE UNAWARE OF THIS, NO ATTEMPT TO RETRIEVE THE INTRODUCER WAS MADE. WHEN THE SAME SCOPE WAS USED FOR ANOTHER PROCEDURE, IT WAS DISCOVERED THAT THE STENT INTRODUCER WAS STILL INSIDE THE SCOPE, AND WAS ADVANCED DOWN AND OUT OF THE SCOPE BY A NEW STENT. THE CUSTOMER RECOMMENDS THAT COOK CHANGE THE COLOR OF THE STENT INTRODUCER (IT IS CURRENTLY BLACK) OR NOT INCLUDE IT AT ALL IN THE STENT SET, AS THE CUSTOMER STATES THEY TYPICALLY DO NOT USE IT. AS FAR AS I KNOW, THE PATIENT HAS NOT BEEN AFFECTED BY THIS EVENT." ADDITIONAL INFORMATION PROVIDED ON 05NOV2019. "WHAT ENDOSCOPE WAS INVOLVED? A DUODENOSCO

  Patient problems: Foreign Body In Patient

  MAUDE report 9358164 ↗
• InjuryNov 13, 2019Unintended Movement; Unintended Movement

  AS REPORTED BY THE INITIAL REPORTER: "I RECEIVED A PRODUCT COMPLAINT ON (B)(6) REGARDING OUR STENT INTRODUCER IN RELATION TO A BILIARY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, "DURING AN ERCP, THE ENDOSCOPIST AND TECHNICIAN USED A STENT INTRODUCER TO ADVANCE A PLASTIC BILIARY STENT INTO THE WORKING CHANNEL OF A DUODENOSCOPE. UNKNOWINGLY, THE STENT INTRODUCER WAS ADVANCED BEYOND THE BIOPSY PORT AND INTO THE SCOPE. BECAUSE THE TEAM WERE UNAWARE OF THIS, NO ATTEMPT TO RETRIEVE THE INTRODUCER WAS MADE. WHEN THE SAME SCOPE WAS USED FOR ANOTHER PROCEDURE, IT WAS DISCOVERED THAT THE STENT INTRODUCER WAS STILL INSIDE THE SCOPE, AND WAS ADVANCED DOWN AND OUT OF THE SCOPE BY A NEW STENT." IT WAS FURTHER REPORTER THAT "THE PATIENT HAS NOT BEEN AFFECTED BY THIS EVENT." ADDITIONAL INFORMATION PROVIDED ON 05NOV2019, A DUODENOSCOPE WAS USED DURING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9317284 ↗