Duette G34036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002340367), received between Nov 20, 2019 and Aug 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Break; Structural Problem; Break; Structural Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO RECEIPT OF ADDITIONAL INFORMATION ON 26 AUG 2025 AND 16 OCT 2025, ALONG WITH COMPLETION OF THE INVESTIGATION ON 20 OCT 2025. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 26 AUG 2025 VIA EMAIL. 1. IS AN ACKNOWLEDGMENT LETTER (FORMAL NOTIFICATION OF THE COMPLAINT BEING RECEIVED) REQUIRED? NO 2. IS ANY ACCOUNT ACTION NEEDED (CREDIT, NO CHARGE REPLACEMENT, NO ACTION, INVESTIGATION RESULTS, ETC.)? 3. WHAT WAS THE DATE OF THE OCCURRENCE? (B)(6) 2025 4. ARE IMAGES AVAILABLE AS PER THE SOURCE EMAIL THERE IS AN IMAGE MENTIONED BUT THERE IS NON-PRESENT. NO 5. WILL THE FACILITY BE REPORTING THIS TO A GOVERNMENT AGENCY (FDA, COMPETENT AUTHORITY, ETC.) NO 6. IS THE DEVICE AVAILABLE FOR RETURN? YES 7. WHAT WAS THE INTENDED PROCEDURE? EMR 8. COULD IT BE CONFIRMED HOW MANY DEVICES ARE BEING REPORTED WITH ISSUES IN THIS COMPLAINT? WE NOW HAVE 2 9. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE NOT USED IN PATIENT 10. WHAT MAKE & MODEL OF ENDOSCOPE WAS USED? NOT SURE- FUJI 11. WAS LUBRICANT ALLOWED BETWEEN THE INSIDE OF THE LIGATOR AND THE ENDOSCOPE'S DISTAL END? N/A, YES, NO NOT SURE 12. WAS THE ENDOSCOPE CURVED OR STRAIGHT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812801 ↗
• MalfunctionApr 11, 2025Contamination; Use of Device Problem; Contamination; Use of Device Problem

  AN ENDOSCOPE PROCEDURE WAS PERFORMED WITH A DUETTE ON A PATIENT IN THE MORNING, THE SCOPE WAS REPROCESSED FOLLOWING IFU THEN THE SCOPE WAS USED ON A DIFFERENT PATIENT LATER ON THE SAME DAY. WHEN AN INSTRUMENT WAS INSERTED INTO THE WORKING CHANNEL OF THE SCOPE A BAND CAME OUT OF THE CHANNEL INTO THE NEXT PATIENT. NO REPORTED PATIENT INJURY. THIS FILE CAPTURES THE ¿BAND CAME OUT OF THE CHANNEL INTO THE NEXT PATIENT. THE FOLLOWING INFORMATION HAS BEEN RECEIVED ON 08APR2025. LOT C2137722. NO REPORTED PATIENT INJURY - THE HOSPITAL HAD INFORMED BOTH PATIENTS OF THIS SCENARIO AND BROUGH THEM FOR BLOOD WORK.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21823900 ↗
• MalfunctionMar 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  PER REP - (B)(6) 2023 - THE DEVICE MISFIRED 3 BANDS THAT RELEASED AT THE SAME TIME AND ONE BAND GOT WRAPPED UP ON THE STRING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. PATIENT OUTCOME: 6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO. 6.3.1.2 WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? -NO. 6.3.1.3 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NO. 6.3.1.4 DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NO. 6.3.1.5 HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -NO. 6.3.1.6 HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO - NOTES: 1.0 RPN PREFIX: DT. 1.1 GENERAL QUESTIONS. 1.1.1 PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. 1.1.2 WHAT MAKE & MODEL OF ENDOSCOPE WAS USED? 1.1.3 WAS A DISPOSABLE CAP USED AT THE BIOPSY PORT? N/A, YES, NO. IF YES, PLEASE LIST THE CAP MANUFACTURER AND PART NUMBER. 1.1.4 WAS SECURE ATTACHMENT OF DUETTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528525 ↗
• MalfunctionDec 31, 2019Use of Device Problem; Use of Device Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS PER EMAIL FROM DISTRICT MANAGER: APPARENTLY THE SNARE WOULD NOT GO THROUGH THE DUETTE HANDLE. I [DISTRICT MANAGER] WILL BE AT THIS ACCT ON MONDAY 12/9 AND WILL FIND MORE OUT ABOUT WHAT HAPPENED. ADDITIONAL REQUEST RECEIVED 23DEC2019 EVENT DESCRIPTION: DT-6 LOT C1544607 EXPIRED ON THE 18-SEP-19, HOWEVER THE DEVICE WAS USED ON THE (B)(6) 2019. THIS FILE IS BEING CREATED TO CAPTURE THE USER ERROR OF AN EXPIRED DEVICE BEING USED ON A PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9535630 ↗
• MalfunctionNov 20, 2019Material Twisted/Bent; Material Twisted/Bent

  AS PER ESOKS TRANSLATION: DEFAULT OF THE DUETTE KIT; THERE WAS A KNOT ON THE WIRE GUIDE. "AS PER COMPLAINT FORM": PRIOR TO USE, THERE WAS A DEFAULT OF THE DUETTE KIT, THERE WAS A KNOT ON THE TRIGGER CORD. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 25TH OCTOBER 2019. THE TRIGGER CORD WAS FOUND TANGLED. FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DEPLOYMENT- BEADED STRING TWISTED'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9350900 ↗