EXALT MODEL D SINGLE USE DUODENOSCOPE - CLINICAL
Report
- Report Number
- 3005099803-2026-01000
- Event Type
- Malfunction
- Date Received
- March 18, 2026
- Date of Event
- June 16, 2025
- Report Date
- April 29, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDT
- PMA / PMN Number
- K193202
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. BLOCK B3: DATE OF EVENT REPRESENTS THE ARTICLE ONLINE PUBLISHING DATE. BLOCK D4, H4: DETAILED MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED TO BSC. GOOD FAITH EFFORTS WERE COMPLETED TO OBTAIN THIS INFORMATION; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED TO DATE. BECAUSE THE PRODUCT INFORMATION IS CURRENTLY UNKNOWN, NO UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE JOURNAL ARTICLE: IYIAD ALABDUL RAZZAK, ET AL. "EFFICACY AND SAFETY OF SINGLE USE DUODENOSCOPES IN COMPARISON TO REUSABLE DUODENOSCOPES FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A SINGLE CENTER EXPERIENCE", WORLD JOURNAL OF GASTROINTESTINAL ENDOSCOPY, 2025; DOI: 10.4253/WJGE.V17.I6.105298.
BLOCK H6: IMDRF CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. BLOCK B3: DATE OF EVENT REPRESENTS THE ARTICLE ONLINE PUBLISHING DATE. BLOCK D4, H4 DETAILED MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED TO BSC. GOOD FAITH EFFORTS WERE COMPLETED TO OBTAIN THIS INFORMATION; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED TO DATE. BECAUSE THE PRODUCT INFORMATION IS CURRENTLY UNKNOWN, NO UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE JOURNAL ARTICLE: IYIAD ALABDUL RAZZAK, ET AL. "EFFICACY AND SAFETY OF SINGLE USE DUODENOSCOPES IN COMPARISON TO REUSABLE DUODENOSCOPES FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A SINGLE CENTER EXPERIENCE", WORLD JOURNAL OF GASTROINTESTINAL ENDOSCOPY, 2025; DOI: 10.4253/WJGE.V17.I6.105298. BLOCK H11: THE DEVICES WERE NOT RETURNED FOR ANALYSIS, AND NO DIRECT DEVICE EVALUATION COULD BE PERFORMED. MEDIA PROVIDED IN THE PUBLICATION INCLUDED IMAGES OF A PATIENT UNDERGOING AN UPPER ENDOSCOPY FOR A GASTRIC ULCER AND PLACEMENT OF CLIPS; HOWEVER, THE DEVICE IN QUESTION WAS NOT SHOWN IN THE IMAGES. AS A RESULT, NO DEVICE MALFUNCTION OR PERFORMANCE ISSUE COULD BE CONFIRMED BASED ON THE AVAILABLE EVIDENCE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED BECAUSE THE SHIP HISTORY REVIEW COULD NOT BE COMPLETED DUE TO THE UNAVAILABLE DOCUMENTATION. BASED ON THE EVENT DESCRIPTION AND INFORMATION PROVIDED BY THE CUSTOMER THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE SCOPE POSITIONING ISSUE AND DEVICE DAMAGED/DEFECTIVE WAS DUE TO THE PHYSICIAN'S TECHNIQUE DURING THE PROCEDURE OR WAS RELATED TO A DEVICE MALFUNCTION. FOR THIS REASON, CAUSE NOT ESTABLISHED IS SELECTED AS THE MOST PROBABLE CAUSE FOR THESE EVENTS. ADDITIONALLY, FOR THE EVENT CANCELLED RESCHEDULED POST SEDATION/SEDATION UNKNOWN, IT HAPPENED DURING THE PROCEDURE, AND THE MOST PROBABLE CAUSE OF THIS REPORTED ISSUE CANNOT BE ESTABLISHED DUE TO LACK OF EVIDENCE. FOR THIS REASON, WILL BE CLASSIFIED AS CAUSE NOT ESTABLISHED.
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING EXALT MODEL D SINGLE-USE DUODENOSCOPE THROUGH THE ARTICLE TITLED: EFFICACY AND SAFETY OF SINGLE USE DUODENOSCOPES IN COMPARISON TO REUSABLE DUODENOSCOPES FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A SINGLE CENTER EXPERIENCE BY IYIAD ALABDUL RAZZAK, ET AL. PER THE ARTICLE, BETWEEN 2020 AND 2023, 133 PATIENTS UNDERGOING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING EITHER EXALT MODEL D OR A REUSABLE SCOPE WERE ENROLLED. 53 PATIENTS WERE ENROLLED IN THE EXALT MODEL D GROUP. SUCCESS RATES AND ADVERSE EVENTS ASSOCIATED WITH BOTH SCOPE TYPES WERE COMPARED. FAILURE TO COMPLETE THE ERCP WAS REPORTED IN TWO CASES DUE TO INABILITY TO CANNULATE THE AMPULLA. AN ADDITIONAL OCCURRENCE OF ERCP FAILURE WAS ATTRIBUTED TO AN UNSPECIFIED MALFUNCTION. PLEASE REFER TO THE CITED ARTICLE FOR COMPLETE DETAILS.
BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING EXALT MODEL D SINGLE-USE DUODENOSCOPE THROUGH THE ARTICLE TITLED: EFFICACY AND SAFETY OF SINGLE USE DUODENOSCOPES IN COMPARISON TO REUSABLE DUODENOSCOPES FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A SINGLE CENTER EXPERIENCE BY IYIAD ALABDUL RAZZAK, ET AL. PER THE ARTICLE, BETWEEN 2020 AND 2023, 133 PATIENTS UNDERGOING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) USING EITHER EXALT MODEL D OR A REUSABLE SCOPE WERE ENROLLED. 53 PATIENTS WERE ENROLLED IN THE EXALT MODEL D GROUP. SUCCESS RATES AND ADVERSE EVENTS ASSOCIATED WITH BOTH SCOPE TYPES WERE COMPARED. FAILURE TO COMPLETE THE ERCP WAS REPORTED IN TWO CASES DUE TO INABILITY TO CANNULATE THE AMPULLA. AN ADDITIONAL OCCURRENCE OF ERCP FAILURE WAS ATTRIBUTED TO AN UNSPECIFIED MALFUNCTION. PLEASE REFER TO THE CITED ARTICLE FOR COMPLETE DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690941 | EXALT MODEL D SINGLE USE DUODENOSCOPE - CLINICAL | DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDT | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |