SINGLE USE DISTAL COVER
Report
- Report Number
- 3003637092-2024-00164
- Event Type
- Injury
- Date Received
- October 16, 2024
- Date of Event
- July 19, 2024
- Report Date
- December 3, 2024
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
- Product Code
- FDT
- UDI-DI
- 04953170441271
- PMA / PMN Number
- K220587
- Removal / Correction Number
- Z-1071-2024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO THE INITIAL MDR AND ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. CORRECTION IS ADDED TO THE FOLLOWING FIELDS FOR INFORMATION INADVERTENTLY LEFT OUT. UPDATES ARE ADDED TO THE FOLLOWING FIELDS BASED ON THE CUSTOMER'S RESPONSE: A2 AND B5. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000449. THIS REPORT HAS BEEN SUBMITTED BY THE USER FACILITY UNDER THIS MDR REPORT NUMBER MW5159416. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. HOWEVER, TESTING WAS PERFORMED USING DISTAL COVERS FROM OTHER LOTS AND THE MAJOR ROOT CAUSE IS AS FOLLOWS: INADEQUATE USABILITY IN THE DESIGN OF THE DISTAL END COVER, WHICH DOES NOT SUPPORT CONSISTENT ATTACHMENT OR DETECTABILITY OF IMPROPER ATTACHMENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT THE DISTAL COVER WAS LIKELY NOT PROPERLY ATTACHED TO THE SCOPE AND EASILY DETACHED DUE TO A LOAD DURING THE PROCEDURE. SINCE IT IS DIFFICULT TO VISUALLY DETECT THE ATTACHMENT OF THIS DEVICE, IT IS POSSIBLE THAT THE DESCRIPTION IN THE PREVIOUS INSTRUCTIONS FOR USE (IFU) MANUAL WAS INSUFFICIENT. HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED. FURTHERMORE, OLYMPUS HAS REVISED THE IFU TO ADD DETAILED INSPECTION AND ATTACHMENT INSTRUCTIONS FOR THE DISTAL COVER. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE IFU WHICH STATE: (IFU AT TIME OF OCCURRENCE) ¿SECTION 8.2- INSPECTION OF THE DISTAL COVER: SHOULD ANY IRREGULARITY BE OBSERVED WHEN INSPECTING THE DISTAL COVER, DO NOT USE IT. A DISTAL COVER WITH IRREGULARITY COULD NOT SERVE THE ENDOSCOPE PROPERLY AND/OR COULD FALL OFF DURING THE EXAMINATION. USING THE ENDOSCOPE WITHOUT THE DISTAL COVER COULD CAUSE PATIENT INJURY. CONFIRM THAT THE DISTAL COVER IS FREE FROM ANY IRREGULARITIES SUCH AS CRACKS, CHIPS, PINHOLES, OR DEFORMATION.¿ (IFU AT TIME OF OCCURRENCE) ¿SECTION 9.3 - ATTACHING THE DISTAL COVER: NEVER USE A DISTAL COVER WITH CRACKS OR PINHOLES. REPLACE IT WITH A NEW ONE. IF A DISTAL COVER WITH CRACKS OR PINHOLES IS USED, IT COULD FALL OFF DURING THE EXAMINATION AND/OR, IT MAY CAUSE THERMAL INJURY DUE TO ELECTRIC CURRENT LEAKS FROM CRACKS OR PINHOLES WHEN HIGH-FREQUENCY CAUTERIZATION TREATMENT IS PERFORMED. ALSO, USING THE DISTAL COVER WITH CRACKS MAY CAUSE PATIENT INJURY DUE TO SHARP EDGES. DO NOT APPLY ANTI-FOGGING PRODUCTS, OLIVE OIL, OR PRODUCTS CONTAINING PETROLEUM-BASED SUBSTANCES (E.G., VASELINE®) TO THE DISTAL COVER OR THE ENDOSCOPE. THESE PRODUCTS MAY CAUSE CRACKS IN THE DISTAL COVER. IF A DISTAL COVER WITH CRACKS IS USED, IT MAY CAUSE PATIENT INJURY SUCH AS: THERMAL INJURY FROM ELECTRIC CURRENT LEAKS WHEN PERFORMING HIGH-FREQUENCY CAUTERIZATION TREATMENT. GENTLY HOLD THE DISTAL PART OF THE BENDING SECTION AND THE DISTAL COVER. ALIGN THE OPENING SIDE OF THE DISTAL COVER WITH THE LENS SIDE OF THE DISTAL END OF THE ENDOSCOPE. PUT YOUR FINGER ONTO THE CENTER ON THE TOP OF THE DISTAL COVER AND PUSH THE TOP OF THE DISTAL COVER STRAIGHT ONTO THE DISTAL END OF THE ENDOSCOPE UNTIL THE HOOK OF THE DISTAL RING IS COMPLETELY VISIBLE WITHIN THE OPENING OF THE DISTAL COVER. HOLD THE DISTAL PART OF THE BENDING SECTION. PULL THE DISTAL COVER GENTLY TO CONFIRM THAT THE DISTAL COVER ON THE DISTAL END OF THE ENDOSCOPE DOES NOT SLIP AND COME OFF. TWIST THE DISTAL COVER GENTLY IN BOTH DIRECTIONS AND CONFIRM THAT THE DISTAL COVER ON THE DISTAL END OF THE ENDOSCOPE DOES NOT SLIP AND COME OFF. CONFIRM THAT THE DISTAL COVER IS FREE OF CRACKS OR DEFORMATION.¿ (CURRENT/ REVISED IFU) ¿ATTACHING THE DISTAL COVER - SECTION 9.3 AND SECTION 9.4¿ ¿SECTION 9.4: THE DISTAL COVER WILL DEFORM WHEN IT IS ATTACHED INTO THE ENDOSCOPE. THEREFORE, IF IT IS ATTACHED CORRECTLY, THE CONNECTION PART WITH THE ENDOSCOPE INSIDE THE DISTAL COVER WILL BECOME DEFORMED.¿ THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION ADDED TO H4, H7, AND H9. ALSO, A CORRECTION HAS BEEN MADE TO H8 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THE AFTER AN UNSPECIFIED PROCEDURE THE DISTAL CAP WAS MISSING FROM THE ENDOSCOPE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE CAP. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS INITIALLY REPORTED THAT THE PATIENT WAS RESEDATED, AND THE CAP WAS RETRIEVED. THE CUSTOMER LATER REPORTED THAT THE PROCEDURE PERFORMED WAS A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, WHICH WAS COMPLETED USING THE SUBJECT DEVICE. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR BOTH PROCEDURES, WHICH TOOK 3 HOURS AND 18 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1033737 | SINGLE USE DISTAL COVER | DISTAL COVER | FDT | OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT | MAJ-2315 | H4115 | 04953170441271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention | TJF-Q190V S/N UNKNOWN |