FDA Adverse Event
Malfunction
Summary report: N
VASO VIEW HEMOPRO
MDR report key: 3050636
·
Received March 14, 2013
Report
- Report Number
- 2242352-2013-00238
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Date of Event
- February 15, 2013
- Report Date
- February 20, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- DXC
- PMA / PMN Number
- K052274
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE HEMOPRO, THE DISSECTION TIP ON THE HEMOPRO DEVICE DID NOT HAVE A POINT OF REFERENCE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108467 | VASO VIEW HEMOPRO | ENDOSCOPIC VESSEL HARVESTING | DXC | MAQUET CARDIOVASCULAR, LLC | VH-3000 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |