FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2
MDR report key: 19182728
·
Received April 25, 2024
Report
- Report Number
- 2242352-2024-00414
- Event Type
- Malfunction
- Date Received
- April 25, 2024
- Report Date
- June 11, 2024
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700406
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN ASSISTANT
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
TW ID (B)(4) SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.
Additional Manufacturer Narrative · 0
TW # (B)(4). CORRECTED SECTION: H6- PROBLEM CODE CHANGED 1408.
Additional Manufacturer Narrative · 0
(B)(4). NO LOT # WAS REPORTED AND NO SPECIFIC EVENT SITE WAS REPORTED, SO THEREFOR NO SHIP HISTORY WAS CONDUCTED.
Description of Event or Problem · 0
RECEIVED INCROWD SURVEY 27399-EVH PMS- (B)(6) 2023, WHERE THEY COMMENTED "OCCASIONALLY THE CONE IS CLOUDY" WHEN ASKED ABOUT THE HARVESTING TOOL HEMOPRO 2 (VH-4000) ENDOSCOPE WITH DISSECTION TIP PROVIDES ADEQUATE VISUALIZATION AND UTILITY WHILE PERFORMING TUNNEL DISSECTION FOR VESSEL HARVESTING.
Description of Event or Problem · 0
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1541581 | VASOVIEW HEMOPRO 2 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-4000 | 00607567700406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |