FDA Adverse Event
Malfunction
Summary report: N
VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
MDR report key: 20077339
·
Received August 27, 2024
Report
- Report Number
- 9610773-2024-32304
- Event Type
- Malfunction
- Date Received
- August 27, 2024
- Date of Event
- August 21, 2024
- Report Date
- December 26, 2024
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- HET
- UDI-DI
- 04042761074971
- PMA / PMN Number
- K190744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
E1/ADDRESS: (B)(6). E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM YOU THAT THE MDR 9610773-2024-32304-00 IS A DUPLICATE COMPLAINT. THE EVENT WAS ALREADY REPORTED UNDER THE MFR # 9610773-2024-32310-00. THEREFORE, THIS EMDR FORM IS CONCLUDED AS DUPLICATE AND VOIDED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A GREEN IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25240 | VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE | LAPAROSCOPE, GYNECOLOGIC | HET | OLYMPUS WINTER & IBE GMBH | WA50042A | 04042761074971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |