VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Report
- Report Number
- 9610773-2024-30511
- Event Type
- Malfunction
- Date Received
- May 14, 2024
- Report Date
- October 8, 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
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE EVALUATION OF THE EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION AND TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H4, H6, H11. CORRECTED FIELDS: D2A (UPDATED TO ¿RIGID VIDEO SCOPE¿), D3 (CHANGED FROM ¿HAMBURG, HAMBURG¿ TO ¿HAMBURG¿), E1 (TITLE UPDATED TO ¿MR.¿), G1 (¿CHANGED FROM ¿HAMBURG, HAMBURG¿ TO ¿HAMBURG¿), H6 MEDICAL DEVICE PROBLEM CODE, H10. THE DEVICE WAS RETURNED TO OLYMPUS REGIONAL REPAIR CENTER FOR THE EVALUATION AND REPORTED PROBLEM WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: VIDEO CABLE BROKEN AND FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS DAMAGE. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE OF THE IMAGE PROBLEM WAS BROKEN VIDEO CABLE AND DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WHICH ARE TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THE THAT THE RIGID VIDEO SCOPE HAD ISSUES WITH THE IMAGE, DEPENDING ON THE POSITION OF THE CABLE, THE IMAGE ON THE RIGHT DISAPPEARS/REAPPEARS, ADDITIONALLY, INTERFERENCES APPEAR IN THE IMAGE. THE EVENT OCCURRED AFTER AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THE THAT THE RIGID VIDEO SCOPE HAD ISSUES WITH THE IMAGE, DEPENDING ON THE POSITION OF THE CABLE, THE IMAGE ON THE RIGHT DISAPPEARS/REAPPEARS, ADDITIONALLY, INTERFERENCES APPEAR IN THE IMAGE. THE EVENT OCCURRED AFTER AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1102740 | VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0° | RIGID VIDEO SCOPE | GCM | OLYMPUS WINTER & IBE GMBH | WA50080A | 04042761083485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |