VASOVIEW HEMOPRO 2
Report
- Report Number
- 2242352-2022-00610
- Event Type
- Malfunction
- Date Received
- July 12, 2022
- Date of Event
- June 2, 2022
- Report Date
- August 16, 2022
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700406
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
TRACKWISE ID: (B)(4).
TRACKWISE #(B)(4). THE LOT # 25162977 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2. VH-1111 SCOPE (NOT THE ISSUE) WOULD NOT SLIDE INTO THE HARVESTING CANNULA (DISPOSABLE) IN ITS DESIGNED POSITION. THIS IS NOT TO BE CONFUSED WITH THE CUTTING/SEALING DEVICE ON THE DISPOSABLE. A NEW KIT WAS PULLED TO COMPLETE THE CASE. NO PATIENT ISSUES AS THE HARVESTING CANNULA WAS NEVER USED ON THE PATIENT.
(B)(4).
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2, WOULD NOT SLIDE ALL THE WAY INTO THE HARVESTING CANNULA AND SEAT INTO THE LOCKED POSITION. A NEW KIT WAS PULLED TO COMPLETE THE CASE. NO PATIENT ISSUES AS THE HARVESTING CANNULA WAS NEVER USED ON THE PATIENT.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721931 | VASOVIEW HEMOPRO 2 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VASOVIEW HEMOPRO 2 | 25162977 | 00607567700406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |