EVIS LUCERA ELITE DUODENOVIDEOSCOPE
Report
- Report Number
- 9610595-2022-00725
- Event Type
- Injury
- Date Received
- August 9, 2022
- Date of Event
- July 10, 2022
- Report Date
- July 26, 2023
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE SUSPECT WAS RETURNED TO OLYMPUS FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE FOUND THE TIP OF THE DISTAL COVER WAS DAMAGED AND WAS EASILY REMOVED FROM THE SCOPE. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, H6, H10. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO THE DISTAL COVER FALLING OFF, LEAVING THE METAL PART OF THE DISTAL END EXPOSED, WHICH MAY DAMAGE INNER BODY OF A PATIENT. THE BELOW CAUSES ARE PRESUMED. ·MAJ-2315 WAS NOT CORRECTLY ATTACHED. ·MAJ-2315 HAD SOME ABNORMALITY LIKE A TEAR AT THE TIME OF ATTACHMENT. THE INSTRUCTIONS FOR USE PROVIDES INFORMATION TO PREVENT THIS EVENT: TJF-Q290V OPERATION MANUAL (RC5079 REVISION 6) HAS DESCRIPTION REGARDING ATTACHING THE DISTAL COVER AS BELOW. 3.5 ATTACHING ACCESSORIES TO THE ENDOSCOPE ATTACHING THE SINGLE USE DISTAL COVER 5 HOLD THE DISTAL PART OF THE BENDING SECTION. PULL THE SINGLE USE DISTAL COVER GENTLY TO CONFIRM THAT THE SINGLE USE DISTAL COVER ON THE DISTAL END OF THE ENDOSCOPE DOES NOT SLIP AND COME OFF.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AN INTERVIEW WAS CONDUCTED BY OLYMPUS WITH THE FACILITY AS PART OF THE ROOT CAUSE INVESTIGATION PER CAPA-200735. IT WAS REPORTED THAT THE FACILITY CURRENTLY USES THE NEW DESIGN OF THE DISTAL COVER (MAJ-2315). REGARDING THE PREVENTION OF THE DETACHMENT OF THE DISTAL COVER FROM RECURRING, THE FACILITY, THE FOLLOWING WAS CONFIRMED: ¿ THE FACILITY DID NOT RECONFIRM THE CORRECT OPERATION METHOD BY CONTACTING OLYMPUS OR ANOTHER EXPERT WITHIN THEIR FACILITY. ¿ THE FACILITY DID NOT CAREFULLY REVIEW AND FOLLOW THE INSTRUCTION MANUAL. ¿ THE FACILITY DID NOT EDUCATE OR CONTINUOUSLY EDUCATE ITS PERSONNEL ABOUT HANDLING METHODS. ¿ THE FACILITY DID NOT INSPECT THE DISTAL COVER PRIOR TO ATTACHMENT. ¿ THE FACILITY DID NOT USE CARE WHEN ATTACHING THE DISTAL COVER, SO THAT IT DOES NOT CRACK. IN ADDITION TO THE ABOVE, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: ¿ THE INTERVIEWEE WAS NOT PRESENT WHEN THE PREVIOUSLY REPORTED COMPLAINT OCCURRED (DETACHMENT OF DISTAL COVER). ¿ AFTER THE REPORTED EVENT (DETACHMENT OF DISTAL COVER) OCCURRED, NO TRAINING WAS PROVIDED TO THE DEVICE USERS INVOLVED. ¿ REGARDING THE DETACHMENT OF THE DISTAL COVER, THE PHYSICIAN STATES THAT HE ¿PUT A LOT OF EFFORT INTO OPERATING THE TREATMENT DEVICE.¿ HOWEVER, THE PHYSICIAN DOES NOT REMEMBER EXACTLY HOW MUCH FORCE HE APPLIED. THE FACILITY IS CURRENTLY ¿NOT WORRIED¿ ABOUT THE DISTAL COVER FALLING OFF. ¿ THE USER IS VERY CAREFUL WHEN INSTALLING THE OLD COVER TO AVOID CRACKS. THE USER VISUALLY CONFIRMS THAT THE COVER DOES NOT COME OFF AND THAT THE HOOK IS FIRMLY HOOKED. ¿ AN EXPERIENCED DEVICE USER WILL COMMUNICATE WITH ALL NEW DEVICE USERS. THERE IS A DOCUMENT (IN FOLDER) WITH INFORMATION AND LEARNING MATERIAL ON OPERATING THE DEVICE. ALTHOUGH IT WAS NOT CONFIRMED, BASED ON THE INFORMATION RECEIVED IT IS ASSUMED THAT THERE HAS BEEN NO CHANGE IN THE STORAGE METHOD OF THE DISTAL COVERS SINCE EXPERIENCING THE DETACHMENT ISSUE. THE DISTAL COVERS ARE KEPT IN THEIR PRODUCT CARTON AND STORED IN A DRAWER. SOME DISTAL COVER STERILIZATION PACKS ARE REMOVED FROM THE PRODUCT CARTON AND STORED IN THE SAME DRAWER. THE FACILITY REPORTED THAT THEY DO NOT KNOW THE SPECIFIC CHEMICALS USED WHEN THE DISTAL COVER DETACHED; THEREFORE, THE INFORMATION BELOW IS BASED ON THE CURRENT PROCESS. ALTHOUGH IT WAS CONFIRMED THAT NO LUBRICANTS ARE APPLIED TO THE DISTAL END OF THE ENDOSCOPE, IT IS POSSIBLE THAT AN ANTI-FOG SOLUTION MAY BE USED. WHETHER THE APPLICATION METHOD IS DIRECT OR SOAKED IN GAUZE DEPENDS ON THE PHYSICIAN PERFORMING THE PROCEDURE. DIMETHICONE (DEFOAMER) IS ADMINISTERED DIRECTLY INTO THE BODY THROUGH THE FORCEPS CHANNEL DURING ENDOSCOPE INSERTION AND SENT TO THE FORCEPS CHANNEL TO LUBRICATE. ACCORDING TO THE PACKAGE INSERT, 2 ML TO 4 ML OF THIS DRUG IS TO BE DILUTED WITH 10 ML OF WATER; HOWEVER, BASED ON THE OBSERVATION BY OLYMPUS, THE FACILITY DOES NOT FOLLOW THIS RECOMMENDED CONCENTRATION. CONTRAST (UROGRAFIN) IS ADMINISTERED THROUGH THE CANNULA DURING THE ENDOSCOPE INSERTION. XYLOCAINE SPRAY (8%) AND XYLOCAINE VISCOUS ARE ADMINISTERED ORALLY TO THE PATIENT BEFORE THE INSPECTION. WATER WITH DIMETHICONE IS USED DURING ENDOSCOPE PREPARATION AND PRE-USE INSPECTION. IN ADDITION TO THE CHEMICALS/SOLUTIONS MENTIONED ABOVE, XYLOCAINE JELLY (2%) AND CAIN ZERO JELLY ARE PRESENT ON THE ENDOSCOPE TOWER IN THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) ROOM. IT WAS CONFIRMED THAT A CRACK HAS NEVER BEEN OBSERVED ON THE DISTAL COVER BEFORE ATTACHING IT TO THE ENDOSCOPE. HOWEVER, ONE TIME WHILE USING THE OLD DESIGN OF THE DISTAL COVER, THE DEVICE CRACKED WHILE INSTALLING IT. THIS HAS NEVER OCCURRED SINCE USING THE NEW DESIGN OF THE DISTAL COVER. THE FACILITY STATES THAT THE DISTAL COVER HAS BECOME EASIER TO INSTALL BECAUSE THE TIP IS NO LONGER ¿BREAKING.¿ THERE HAVE BEEN NO CRACKS OBSERVED ON THE REAR END OF THE DEVICE.
THE FACILITY REPORTED TO OLYMPUS DURING A THERAPEUTIC STONE REMOVAL PROCEDURE, THE DISTAL COVER FELL OFF OF THE ENDOSCOPE AND FELL INTO THE PATIENT WHILE THE PHYSICIAN WAS PICKING STONES WITH A BASKET FORCEPS. THE PHYSICIAN HEARD A NOISE WHEN THE DISTAL COVER FELL OFF. THE PHYSICIAN USED AN UNKNOWN ENDOSCOPE TO RETRIEVE THE DISTAL COVER FROM INSIDE THE PATIENT. THE CUSTOMER REPORTED THE PROCEDURE WAS COMPLETED HOWEVER NO ADDITIONAL DETAIL WAS PROVIDED. THE CUSTOMER ALSO REPORTED NO INJURY TO THE PATIENT OCCURRED. IT IS UNKNOWN IF THERE WAS A PROCEDURAL DELAY. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES TWO (2) REPORTS: PATIENT IDENTIFIER (B)(6): MAJ-2315, UNK. PATIENT IDENTIFIER (B)(6): TJF-Q290V, 2111025. THIS REPORT IS 2 OF 2 FOR PATIENT IDENTIFIER (B)(6) TJF-Q290V, 2111025.
THE CUSTOMER PROVIDED ADDITIONAL INFORMATION: DURING THE THERAPEUTIC PROCEDURE, THE SURGEON WAS PICKING STONES WITH BASKET FORCEPS WHEN IT MADE A NOISE AND THE CAP FELL OFF IN AN UNKNOWN LOCATION OF THE PATIENT. IT IS UNKNOWN WHEN DURING THE PROCEDURE THIS HAPPENED. AFTER COMPLETION OF THE PROCEDURE, ANOTHER ENDOSCOPE WAS USED TO RETRIEVE THE RETAINED DISTAL COVER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE BASKET MANUFACTURER, MODEL AND SERIAL NUMBER ARE UNKNOWN. IT IS UNKNOWN IF ANY CHEMICALS WERE USED DURING THE PROCEDURE TO THE TIP OF THE SCOPE OR THE DISTAL COVER. THE CUSTOMER CONFIRMED THE DISTAL COVER WAS NOT DAMAGED BEFORE USE. IT IS UNKNOWN IF THE DISTAL COVER WAS TESTED TO ENSURE SECURE ATTACHMENT TO THE SCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248506 | EVIS LUCERA ELITE DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q290V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R | MAJ-2315 |