EXALT MODEL D SINGLE-USE DUODENOSCOPE
Report
- Report Number
- 3005099803-2023-05494
- Event Type
- Malfunction
- Date Received
- October 12, 2023
- Date of Event
- September 15, 2023
- Report Date
- November 16, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FDT
- UDI-DI
- 08714729993605
- PMA / PMN Number
- K193202
- Removal / Correction Number
- 97090504-FA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR-QUALITY IMAGE. BLOCK H9 (CORRECTION/REMOVAL REPORTING #). ON OCTOBER 3, 2023, BOSTON SCIENTIFIC ISSUED A PRODUCT REMOVAL NOTICE (97090504-FA) TO RECALL CERTAIN BATCHES OF THE EXALT MODEL D SINGLE-USE DUODENOSCOPE FOLLOWING AN INCREASE IN REPORTS OF POOR IMAGE QUALITY DUE TO FLUID INGRESS IN THE LENS. TO ADDRESS THIS KNOWN, UNCOMMON MALFUNCTION, BOSTON SCIENTIFIC HAS IMPLEMENTED CORRECTIVE CHANGES FOR REPLACEMENT EXALT MODEL D SCOPES.
BLOCK H6: IMDRF DEVICE CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR-QUALITY IMAGE. BLOCK H9 (CORRECTION/REMOVAL REPORTING #) ON OCTOBER 3, 2023, BOSTON SCIENTIFIC ISSUED A PRODUCT REMOVAL NOTICE (97090504-FA) TO RECALL CERTAIN BATCHES OF THE EXALT MODEL D SINGLE-USE DUODENOSCOPE FOLLOWING AN INCREASE IN REPORTS OF POOR IMAGE QUALITY DUE TO FLUID INGRESS IN THE LENS. TO ADDRESS THIS KNOWN, UNCOMMON MALFUNCTION, BOSTON SCIENTIFIC HAS IMPLEMENTED CORRECTIVE CHANGES FOR REPLACEMENT EXALT MODEL D SCOPES. BLOCK H10: ANALYSIS OF THE RETURNED EXALT MODEL D SINGLE USE DUODENOSCOPE REVEALED A POOR-QUALITY IMAGE DUE TO RESIDUE ON THE LENS SURFACE. ADDITIONALLY, POOR-QUALITY IMAGES AND FLUID INGRESS IN THE LENS ASSEMBLY WERE OBSERVED WHEN INSUFFLATION WAS PERFORMED AFTER IRRIGATION. FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN ACCORDANCE WITH LABELING/PER THE INSTRUCTIONS FOR USE (IFU). VISUAL INSPECTION OF THE RETURNED DEVICE NOTED NO DAMAGE ON THE UMBILICUS OR INSERTION PORTION OF THE SCOPE AND NO DAMAGE WAS OBSERVED TO THE ELEVATOR OR WORKING CHANNEL AND IRRIGATION LUMEN EXITS ASSOCIATED WITH THE TIP OF THE DEVICE. NO FLUID OR FOGGING WAS OBSERVED INSIDE THE LENS ASSEMBLY. NO DAMAGE WAS OBSERVED TO THE LENS-SEALING EPOXY. RESIDUE WAS OBSERVED ON THE SURFACE OF THE LENS. DEVICE IMAGING WAS TESTED BY PLUGGING THE UMBILICUS CONNECTOR INTO A CONTROLLER, AND A LIVE IMAGE WAS DISPLAYED, OBSTRUCTED BY RESIDUE ON THE SURFACE. THE SCOPE WAS TESTED FOR ARTICULATION AND ELEVATOR ACTUATION USING THE KNOBS AND THUMB LEVER ON THE HANDLE; NO FUNCTIONAL ISSUES WERE IDENTIFIED. DURING PRODUCT ANALYSIS, A POOR-QUALITY IMAGE WAS OBSERVED WHEN THE DEVICE WAS TESTED FOR SUSCEPTIBILITY TO CONDENSATION OR FLUID INGRESS IN THE LENS. AN ORCA AIR/WATER (A/W) BUTTON WAS COVERED TO TEST INSUFFLATION. WHEN THE SCOPE WAS INSUFFLATED, NO AIR-FLOW ISSUES WERE OBSERVED, AND NO CHANGES TO THE IMAGE WAS OBSERVED. THE ORCA A/W BUTTON WAS DEPRESSED TO TEST IRRIGATION; NO IRRIGATION ISSUES WERE OBSERVED, AND A FLOW OF WATER OVER THE CAMERA WAS SEEN IN THE LIVE IMAGE. WHEN IRRIGATION WAS STOPPED, THE POOR-QUALITY IMAGE DUE TO THE SURFACE RESIDUE IMPROVED. INSUFFLATION WAS REPEATED AND A POOR-QUALITY IMAGE WAS OBSERVED; A VISUAL ARTIFACT (APPEARING AS A COLLECTION OF BUBBLES RESEMBLING A HONEYCOMB) APPEARED ON THE SCREEN. THE CAMERA WAS VISUALLY INSPECTED, AND CONDENSATION WAS OBSERVED INSIDE THE LENS. THEREFORE, THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE CAMERA ASSEMBLY REVEALED CONDENSATION ON THE LENS. WHEN THE ORCA A/W BUTTON WAS DEPRESSED TO TEST IRRIGATION, NO WATER-FLOW ISSUES WERE OBSERVED; A FLOW OF WATER OVER THE CAMERA WAS SEEN IN THE LIVE IMAGE. THREE CYCLES OF INSUFFLATION AND IRRIGATION WERE REPEATED; THE LENS CONDENSATION AND POOR-QUALITY IMAGE HAD CLEARED DURING TESTING AND DID NOT RETURN. ON OCTOBER 3, 2023, BOSTON SCIENTIFIC ISSUED A PRODUCT REMOVAL NOTICE (97090504-FA) FOR CERTAIN BATCHES OF THE EXALT MODEL D SINGLE-USE DUODENOSCOPE FOLLOWING AN INCREASE IN REPORTS OF POOR IMAGE QUALITY DUE TO FLUID INGRESS IN THE LENS, AS OBSERVED CLINICALLY IN THIS CASE AND REPLICATED DURING LABORATORY TESTING OF THE RETURNED DEVICE. THE REFERENCED DEVICE WAS INCLUDED WITHIN THIS RECALL, AND THE RETURNED DEVICE ANALYSIS HAS CONFIRMED OBSERVATIONS/FINDINGS CONSISTENT WITH THE DESCRIBED BEHAVIOR. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION FOUND THAT POOR-QUALITY IMAGE ISSUES ARE RELATED TO THE PRESENCE OF FLUID AND CONDENSATION INSIDE THE LENS ASSEMBLY. BOSTON SCIENTIFIC HAS SINCE IMPLEMENTED CORRECTIVE CHANGES FOR REPLACEMENT EXALT MODEL D SCOPES. BOSTON SCIENTIFIC'S PRODUCT PERFORMANCE MONITORING CONFIRMS THAT THE EXALT MODEL D SINGLE-USE DUODENOSCOPE IS PERFORMING WITHIN ESTABLISHED DESIGN, SAFETY, AND ANTICIPATED PRODUCT PERFORMANCE EXPECTATIONS, AND CONTINUES TO MEET ITS INTENDED USE WITH RESPECT TO SAFETY AND PERFORMANCE. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE CAUSE TRACED TO DEVICE DESIGN, WHICH INDICATES THAT THE PROBLEMS WERE TRACED TO THE IMAGER DESIGN CHANGE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CANNULATE. HOWEVER, THE VISUALIZATION DETERIORATED DUE TO A "HONEYCOMB" IMAGE EFFECT ON THE SCREEN THAT WAS UNABLE TO BE CLEARED. THEREFORE, THE PHYSICIAN DECIDED TO USE A REUSABLE SCOPE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CANNULATE. HOWEVER, THE VISUALIZATION DETERIORATED DUE TO A "HONEYCOMB" IMAGE EFFECT ON THE SCREEN THAT WAS UNABLE TO BE CLEARED. THEREFORE, THE PHYSICIAN DECIDED TO USE A REUSABLE SCOPE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1312803 | EXALT MODEL D SINGLE-USE DUODENOSCOPE | DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID | FDT | BOSTON SCIENTIFIC CORPORATION | M00542421 | 0031683921 | 08714729993605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |