FDA Adverse Event
Malfunction
Summary report: N
DW ARTHROSCOPY FLUID MANAGEMENT DEV
MDR report key: 19570490
·
Received June 19, 2024
Report
- Report Number
- 1220246-2024-06210
- Event Type
- Malfunction
- Date Received
- June 19, 2024
- Date of Event
- August 31, 2021
- Report Date
- June 19, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- HRX
- UDI-DI
- 00888867039377
- PMA / PMN Number
- K083707
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT IS NOT CONFIRMED. THE UNIT PASSED ALL FLOW RATE TESTS.
Description of Event or Problem · 0
IT WAS REPORTED THE PUMP WOULD NOT CIRCULATE FLUID. CASE WAS COMPLETED USING ANOTHER PUMP. NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 550249 | DW ARTHROSCOPY FLUID MANAGEMENT DEV | ARTHROSCOPE AND ACCESSORIES | HRX | ARTHREX, INC. | DW ARTHROSCOPY FLUID MANAGEMENT DEV | 10158389 | 00888867039377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |