FDA Adverse Event
Malfunction
Summary report: N
JAZZ
MDR report key: 21853135
·
Received April 17, 2025
Report
- Report Number
- 3020707080-2025-00003
- Event Type
- Malfunction
- Date Received
- April 17, 2025
- Date of Event
- February 15, 2022
- Report Date
- May 13, 2025
- Manufacturer
- FUJIFILM MEDWORK GMBH
- Product Code
- ODC
- UDI-DI
- 04044503055828
- PMA / PMN Number
- K210625
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATE: REFERENCING MDR 1000513161-2025-00014 (SUBMITTED ON APRIL 22ND, 2025) IN BLOCK H10 IN SUPPLEMENTAL MANUFACTURER MDR 3020707080-2025-00003. REF INITIAL REPORT #3020707080-2022-00001, REF INITIAL MANUFACTURER MDR #3020707080-2025-00003, REF HCUS COMP # (B)(4), REF FFMW COMP # (B)(4).
Additional Manufacturer Narrative · 0
REF HCUS COMP#: (B)(4). REF FFMW COMP#: (B)(4). ON MARCH 4TH, 2022, A COMPLAINT WAS RECEIVED, BUT IT WAS NEVER EVALUATED FOR REPORTABILITY TO THE FDA. THIS WAS IDENTIFIED DURING AN FDA-INSPECTION ON MARCH 25TH 2025, THEREFORE, FUJIFILM MEDWORK GMBH IS REPORTING IT NOW.
Description of Event or Problem · 0
NO PRODUCTS CAN BE PUSHED THROUGH THE OPENING WITHOUT PERFORATING THE FROG. THIS PROBLEM ONLY OCCURRED WITH THE LAST BATCH THAT WAS DELIVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107057 | JAZZ | ENDOSCOPE CHANNEL ACCESSORY | ODC | FUJIFILM MEDWORK GMBH | VAL1-G7-50 | 22250071 | 04044503055828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |