FDA Adverse Event
Malfunction
Summary report: N
MEDIVATOR ENDOGATOR IRRIGATION TUBING
MDR report key: 22817366
·
Received August 15, 2025
Report
- Report Number
- MW5174645
- Event Type
- Malfunction
- Date Received
- August 15, 2025
- Date of Event
- July 23, 2025
- Report Date
- August 13, 2025
- Manufacturer
- MEDIVATORS INC
- Product Code
- OCX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ENDOGATOR IRRIGATION TUBING HOOKED UP TO ENDOSCOPE AND NO WATER WOULD COME THROUGH. THIS WAS DISCOVERED PRIOR TO PATIENT INVOLVEMENT- NO PATIENT HARM. LOT 1000281937, EXP- 04/17/2028.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1628182 | MEDIVATOR ENDOGATOR IRRIGATION TUBING | ENDOSCOPIC IRRIGATION/SUCTION SYSTEM | OCX | MEDIVATORS INC | 1000281937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |