FDA Adverse Event
Malfunction
Summary report: N
VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
MDR report key: 20028779
·
Received August 22, 2024
Report
- Report Number
- 9610773-2024-32174
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- August 8, 2024
- Report Date
- August 16, 2024
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- GCM
- UDI-DI
- 04042761083485
- PMA / PMN Number
- K193026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO OLYMPUS AND THE EVALUATION FOUND MINOR SCRATCHES ON DISTAL EDGE BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: MINOR SCRATCHES ON DISTAL EDGE WAS CONFIRMED DUE TO FRICTION PROBLEM IDENTIFIED. THE MOST PROBABLE ROOT CAUSE TRACED TO COMPONENT FAILURE. A DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE
Description of Event or Problem · 0
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED MINOR SCRATCHES ON DISTAL EDGE THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2178838 | VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0° | RIGID VIDEO LAPAROSCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50080A | 04042761083485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |