FDA Adverse Event
Malfunction
Summary report: N
NANOSCOPE CONSOLE
MDR report key: 19568239
·
Received June 19, 2024
Report
- Report Number
- 1220246-2024-06158
- Event Type
- Malfunction
- Date Received
- June 19, 2024
- Date of Event
- April 30, 2021
- Report Date
- June 19, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- GCJ
- UDI-DI
- 00888867299580
- PMA / PMN Number
- K201134
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. (NOT RETURNED) DEVICE NOT EXPECTED TO BE RECEIVED; NO FURTHER. INFORMATION AVAILABLE
Description of Event or Problem · 0
IT WAS REPORTED THAT PRINTING WAS NOT AVAILABLE WHILE USING THE AR-3200-0030 NANOSCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595257 | NANOSCOPE CONSOLE | LAPAROSCOPE | GCJ | ARTHREX, INC. | NANOSCOPE CONSOLE | UNK | 00888867299580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |