URETERO-RENO FIBERSCOPE
Report
- Report Number
- 9610595-2024-15804
- Event Type
- Injury
- Date Received
- August 7, 2024
- Date of Event
- July 12, 2024
- Report Date
- November 14, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FGB
- UDI-DI
- 04953170340802
- PMA / PMN Number
- K172298
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 501
Narratives
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION TO THE INITIAL REPORT AND PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000384.
THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE SUBJECT DEVICE WAS EVALUATED BY OLYMPUS, AND DEBRIS FALLING FROM THE DEVICE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 6 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT SOLID LUBRICANTS FILLED IN THE INSERTION SECTION AND FELL OFF AND INTO THE PATIENT'S BODY DUE TO LEAKAGE FROM THE BIOPSY CHANNEL. HOWEVER, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: CHAPTER 3 - PREPARATION AND INSPECTION: 3.1 THE WORKFLOW OF PREPARATION AND INSPECTION ¿BEFORE EACH CASE, PREPARE AND INSPECT THIS ENDOSCOPE AS INSTRUCTED BELOW. INSPECT OTHER EQUIPMENT TO BE USED WITH THIS ENDOSCOPE AS INSTRUCTED IN THEIR RESPECTIVE INSTRUCTION MANUALS. SHOULD ANY IRREGULARITY BE OBSERVED AFTER INSPECTION, FOLLOW THE INSTRUCTIONS AS DESCRIBED IN CHAPTER 5, ¿TROUBLESHOOTING¿. IF THE ENDOSCOPE MALFUNCTIONS, DO NOT USE IT.¿ ¿WARNING: NEVER USE THE ENDOSCOPE ON A PATIENT IF ANY IRREGULARITY IS OBSERVED. THE IRREGULAR ENDOSCOPE MAY COMPROMISE PATIENT OR USER SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. IN ADDITION, IT MAY POSE AN INFECTION CONTROL RISK.¿ THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. B5 UPDATED ACCORDINGLY. ALSO, AN UPDATE HAS BEEN MADE TO H3 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED DURING A URETEROSCOPY PROCEDURE, A LITTLE PART BROKE OFF THE END OF THE URETERO-RENO FIBERSCOPE. THE PIECES WERE RETRIEVED WITH A FORCEPS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE DUE TO THE REPORTED EVENT, WHICH EXTENDED THE PATIENT'S ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED, THE PHYSICIAN WAS USING A FLEXIBLE SCOPE, DURING A UNSPECIFIED URETEROSCOPY. AND AS LITTLE PART BROKE OFF THE END OF THE SCOPE. THE PHYSICIAN BELIEVES, THAT THEY WERE ABLE TO RETRIEVE THE PART. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
IT WAS REPORTED BY THE FACILITY THAT THE DEVICE WAS ADEQUATELY REPROCESSED. ALSO, THE DEVICE WAS INSPECTED PRIOR TO USE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) MANUAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265511 | URETERO-RENO FIBERSCOPE | URETERO-RENO FIBERSCOPE | FGB | AIZU OLYMPUS CO., LTD. | URF-P6 | 04953170340802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |