FDA Adverse Event
Malfunction
Summary report: N
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
MDR report key: 12708404
·
Received October 27, 2021
Report
- Report Number
- 8010047-2021-13723
- Event Type
- Malfunction
- Date Received
- October 27, 2021
- Report Date
- October 28, 2021
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- GCJ
- PMA / PMN Number
- K080948
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT THE PHENOMENON OCCURRED DUE TO FAILURE OF THE IMAGE SENSOR UNIT OR CIRCUIT BOARD INSIDE THE SCOPE CONNECTOR.
Description of Event or Problem · 0
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) ON OCTOBER 5, 2021, IT WAS FOUND THAT THERE WAS IMAGE NOISE WHEN THE BENDING SECTION WAS ANGLED.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1605341 | ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE | FLEX DEFLECTABLE VIDEOSCOPE | GCJ | OLYMPUS MEDICAL SYSTEMS CORP. | LTF-S190-5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |