FDA Adverse Event
Malfunction
Summary report: N
4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE
MDR report key: 19288531
·
Received May 10, 2024
Report
- Report Number
- 1220246-2024-03111
- Event Type
- Malfunction
- Date Received
- May 10, 2024
- Date of Event
- March 7, 2022
- Report Date
- May 10, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- GCJ
- UDI-DI
- 00888867348844
- PMA / PMN Number
- K202582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. THE EVALUATION CONFIRMED THE REPORTED EVENT WAS DUE TO NORMAL WEAR AND TEAR.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CONNECTION BETWEEN CAMERA AND OPTICS IS TOO LOOSE. IMAGE WOBBLES DURING THE WORK. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2519174 | 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE | LAPAROSCOPE | GCJ | ARTHREX, INC. | 4K SYNERGYID CAMERA HEAD, AUTOCLAVABLE | 11531853 | 00888867348844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |