FDA Adverse Event
Malfunction
Summary report: N
NANOSCOPE CONSOLE
MDR report key: 19211510
·
Received April 30, 2024
Report
- Report Number
- 1220246-2024-02580
- Event Type
- Malfunction
- Date Received
- April 30, 2024
- Date of Event
- June 7, 2021
- Report Date
- April 30, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- GCJ
- UDI-DI
- 00888867299580
- PMA / PMN Number
- K201134
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- 003
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. (MISUSE) THIS EVALUATION DETERMINED THAT THE REPORTED EVENT OCCURRED DUE TO MISUSE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE AR-3200-0030 NANOSCOPE CONSOLE ONLY HAS A BLACK SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171917 | NANOSCOPE CONSOLE | LAPAROSCOPE | GCJ | ARTHREX, INC. | NANOSCOPE CONSOLE | 202022 | 00888867299580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |