SINGLE USE DISTAL COVER
Report
- Report Number
- 2429304-2025-00230
- Event Type
- Injury
- Date Received
- August 19, 2025
- Date of Event
- July 24, 2025
- Report Date
- September 17, 2025
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
- Product Code
- FDT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER. THIS REPORT IS BEING SUPPLEMENTED TO CORRECT D4 - UNIQUE IDENTIFIER (UDI) NUMBER. SINCE THE LOT NUMBER IS UNKNOWN AT THIS TIME, THE UDI IS EITHER (B)(4) OR (B)(4) DEPENDING ON THE LOT NUMBER USED.
CORRECTION IS BEING MADE TO THE PREVIOUSLY SUBMITTED IMPORTER REPORT WITH REFERENCE NUMBER: 2429304-2025-00230-02. CORRECTED FIELD: F6: DATE USER FACILITY/IMPORTER WAS AWARE, WHICH WAS NOT LATE. THE CORRECT DATE WAS 09/15/2025.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECT A1: PATIENT IDENTIFIER FROM (B)(6) TO (B)(6) AND F10 HEALTH EFFECT: CLINICAL CODE FROM E2403: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS TO E2008: FOREIGN BODY IN PATIENT.
THE DAY AFTER A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, AFTER THE PATIENT WOKE UP THEY DISCOVERED THAT THE DISTAL COVER HAD FALLEN OFF THE PATIENT. THERE WAS NO FURTHER INFORMATION ON ANY DIAGNOSTIC IMAGING DONE TO CONFIRM DEVICE FALL OUT, AND NO INFORMATION ON ANY MEDICAL INTERVENTION DONE TO RETRIEVE THE FALLEN DEVICE. THERE ARE ALSO NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1394498 | SINGLE USE DISTAL COVER | DISTAL COVER | FDT | OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT | MAJ-2315 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | TJF-Q190V |