FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW HEMOPRO 2
MDR report key: 19183118
·
Received April 25, 2024
Report
- Report Number
- 2242352-2024-00421
- Event Type
- Malfunction
- Date Received
- April 25, 2024
- Report Date
- June 10, 2024
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700406
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 TO 1408.
Additional Manufacturer Narrative · 0
TRACKWISE ID#:(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- JULY 2023, WHERE THEY COMMENTED "AGAIN SOMETIMES THE CONE COMES CLOUDY STRAIGHT OUT OF THE KIT" WHEN ASKED ABOUT THE HARVESTING TOOL HEMOPRO 2 (VH-4000) THE DISSECTION TIP PROVIDES VISIBILITY DURING DISSECTION WHEN ATTACHED TO THE 7MM ENDOSCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1146046 | VASOVIEW HEMOPRO 2 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-4000 | 00607567700406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |