EVIS EXERA III DUODENOVIDEOSCOPE
Report
- Report Number
- 9610595-2023-19916
- Event Type
- Injury
- Date Received
- December 19, 2023
- Report Date
- July 1, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- UDI-DI
- 04953170405563
- PMA / PMN Number
- K220587
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5 AND D10. CORRECTION ALSO ADDED TO H4 FOR INFORMATION INADVERTENTLY MISSED IN THE INITIAL MDR.
THE SUSPECT DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00411.
THIS MDR IS BEING SUPPLEMENTED TO UPDATE B5 AND PROVIDE CORRECTION TO THE INITIAL MDR WITH INFORMATION INADVERTENTLY LEFT OUT. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304 - 2023 - 00411-1.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS, A DEVICE INSPECTION COULD NOT BE PERFORMED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM. INSPECTION OF THE INSTRUMENT CHANNEL AND FORCEPS ELEVATOR: WARNING CHECK THE MOVEMENT OF THE ENDOTHERAPY ACCESSORY BY OPERATING THE ELEVATOR CONTROL LEVER SEVERAL TIMES TO RAISE THE FORCEPS ELEVATOR. OTHERWISE, THE ENDOTHERAPY ACCESSORY MAY MOVE IN UNEXPECTED DIRECTIONS, AND PATIENT INJURY, BLEEDING, AND/OR PERFORATION MAY RESULT. INSERT THE ENDOTHERAPY ACCESSORY THROUGH THE BIOPSY VALVE. CONFIRM THAT THE ENDOTHERAPY ACCESSORY EXTENDS SMOOTHLY FROM THE DISTAL END OF THE ENDOSCOPE. ALSO, MAKE SURE THAT NO FOREIGN OBJECTS COME OUT OF THE DISTAL END OF THE ENDOSCOPE.¿. ¿4.3 USING ENDOTHERAPY ACCESSORIES: WARNING: IF INSERTION OR WITHDRAWAL OF ENDOTHERAPY ACCESSORIES IS DIFFICULT, STRAIGHTEN THE BENDING SECTION AS MUCH AS POSSIBLE WITHOUT LOSING THE ENDOSCOPIC IMAGE. INSERTING OR WITHDRAWING ENDOTHERAPY ACCESSORIES WITH EXCESSIVE FORCE MAY DAMAGE THE INSTRUMENT CHANNEL OR ENDOTHERAPY ACCESSORIES AND COULD CAUSE SOME PARTS TO FALL OFF AND/OR CAUSE PATIENT INJURY. WHILE RAISING THE FORCEPS ELEVATOR, DO NOT INSERT OR WITHDRAW THE ENDOTHERAPY ACCESSORY WITH EXCESSIVE FORCE, OPEN OR CLOSE THE DISTAL END OF THE ENDOTHERAPY ACCESSORY, OR EXTEND THE NEEDLE OF THE INSTRUMENT. THIS COULD DAMAGE THE INSTRUMENT CHANNEL AND/OR THE ENDOTHERAPY ACCESSORY AND COULD CAUSE PATIENT INJURY, BLEEDING, AND/OR PERFORATION. IF THE ENDOTHERAPY ACCESSORY CANNOT BE INSERTED OR WITHDRAWN, THE DISTAL END OF THE ENDOTHERAPY ACCESSORY CANNOT BE OPENED OR CLOSED, OR THE NEEDLE OF THE INSTRUMENT CANNOT BE EXTENDED, MOVE THE ELEVATOR CONTROL LEVER IN THE OPPOSITE DIRECTION OF THE ¿U¿ DIRECTION TO LOWER THE FORCEPS ELEVATOR.¿. ¿5.2 TROUBLESHOOTING GUIDE ENDOTHERAPY ACCESSORIES:. THE ENDOTHERAPY ACCESSORY DOES NOT PASS THROUGH THE INSTRUMENT CHANNEL SMOOTHLY. AN INCOMPATIBLE ENDOTHERAPY ACCESSORY IS BEING USED. REFER TO ¿COMBINATION EQUIPMENT¿ ON PAGE 111 AND SELECT A COMPATIBLE ENDOTHERAPY ACCESSORY.¿ THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. B5 UPDATED ACCORDINGLY. ALSO, INFORMATION HAS BEEN ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS ADDITIONALLY REPORTED THAT IT WAS HARD TO PUSH THE CANNULA THROUGH THE SCOPE AND ALSO THAT WHEN THEY ARE MOVING OVER THE ELEVATOR, IT FELT LIKE IT WAS GETTING CAUGHT. THE SCOPE ALSO FELT TIGHT AND VERY HARD TO GET IN THE RIGHT POSITION. THE CUSTOMER WAS USING A NON-OLYMPUS GUIDEWIRE WHEN THE FRICTION AND POSITIONING ISSUE OCCURRED. IT WAS FURTHER CLARIFIED THAT THE PROCEDURE WAS NOT CANCELLED.
AN OLYMPUS REPRESENTATIVE INITIALLY REPORTED ON BEHALF OF THE CUSTOMER THAT AFTER RECEIVING THE SCOPES BACK FROM REPAIR, THEY ARE STILL EXPERIENCING CHANNEL AND ELEVATOR ISSUES WITH ITEMS HAVING ISSUES WITH FRICTION WHEN SENDING ITEMS DOWN THE SCOPE CHANNEL. THE DOCTORS ARE ALSO HAVING ISSUES GETTING IN POSITION WITH THE ELEVATOR. THIS IS REPORTEDLY AN ONGOING ISSUE FOR ALL CASES REQUIRING THE SCOPE AND HAVE BEEN OBSERVED IN BOTH THERAPEUTIC AND DIAGNOSTIC PROCEDURES. THE INTENDED PROCEDURE WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WHICH COULD NOT BE COMPLETED AND WAS DEFERRED TO INTERVENTIONAL RADIOLOGY (IR). THE PROCEDURE COULD THEN BE COMPLETED WITH IR. THE PATIENT IS STABLE. OLYMPUS RECEIVED FURTHER INFORMATION CLARIFYING THAT THE ISSUES WERE SEEN IN TWO SCOPES (SERIAL NUMBERS (B)(6)). THERE WAS A DELAY IN PATIENT CARE THAT RESULTED IN DEFERMENT TO THE IR DEPARTMENT FOR INTERVENTION, WHICH IS ONGOING WITH MULTIPLE PATIENTS. THE CUSTOMER CLARIFIED THAT PROCEDURES WERE BEING DONE URGENTLY AND WERE DEFERRED TO IR IMMEDIATELY FOR COMPLETION OF PROCEDURES. THE PATIENTS ARE STABLE. THE EXACT NUMBER OF PATIENTS/PROCEDURES AFFECTED ARE UNKNOWN. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - PATIENT 1 (TJF-Q190V/2230575). (B)(6)- UNSPECIFIED NUMBER OF MULTIPLE PATIENTS (TJF-Q190V/2230575). (B)(6)- PATIENT 1 (TJF-Q190V/2230581). (B)(6)- UNSPECIFIED NUMBER OF MULTIPLE PATIENTS (TJF-Q190V/2230581). THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).
IT WAS REPORTED THAT AFTER RECEIVING THE DUODENOVIDEOSCOPE BACK FROM REPAIR, FRICTION WAS NOTED WHEN SENDING ITEMS DOWN THE SCOPE CHANNEL AND THE ELEVATOR IS DIFFICULT TO POSITION. AT THE TIME OF EVENT, THE PATIENT WAS UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), WHICH COULD NOT BE COMPLETED AS THE PHYSICIAN WAS UNABLE TO MANEUVER THE SCOPE TO ACCESS THE COMMON BILE DUCT CAUSING A DELAY IN PATIENT CARE. IT WAS RELAYED THAT THE PATIENT WAS STABLE. IT WAS FURTHER RELAYED THAT THE PROCEDURE WAS DEFERRED TO INTERVENTIONAL RADIOLOGY (IR) AS IT HAD TO BE COMPLETED URGENTLY. NO SPECIFIC DETAILS WERE PROVIDED. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER CONTACT BUT HAS NOT BEEN PROVIDED AT THIS TIME.
IT WAS REPORTED THAT SINCE SEPTEMBER 2023, THE ISSUE OCCURRED DURING MORE THAN 65 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURES (ERCPS). THE REPORTED ISSUE INVOLVED PATIENTS OF DIFFERENT AGES, WEIGHTS, GENDER, AND ETHNICITIES. ALTHOUGH REQUESTED, SPECIFIC PATIENT DEMOGRAPHICS WERE NOT PROVIDED. FURTHERMORE, THE PHYSICIANS AT THE FACILITY STATED THAT THE ENDOSCOPES WERE UNUSABLE. AS A RESULT, THE ERCPS PROCEDURES WERE EITHER RESCHEDULED OR CANCELLED. ALTHOUGH IN-SERVICE/TRAINING WAS CONDUCTED, THE FACILITY REPORTED THAT THE ISSUE WITH THE ENDOSCOPES IS ONGOING. AN OLYMPUS REPRESENTATIVE CONDUCTED AN ONSITE VISIT AT THE FACILITY TO ASSESS THE ENDOSCOPES AND PRESENT ON PROPER USE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1957446 | EVIS EXERA III DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q190V | 04953170405563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | BOSTON SCIENTIFIC RX 44 TOME WITH JAGWIRE .035 |