VASOVIEW HEMOPRO 2
Report
- Report Number
- 2242352-2024-0001045
- Event Type
- Malfunction
- Date Received
- September 17, 2024
- Date of Event
- August 23, 2024
- Report Date
- October 24, 2024
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700406
- PMA / PMN Number
- K101274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 501
Narratives
TRACKWISE ID#: (B)(4). CORRECTED SECTION UNIQUE IDENTIFIER (UDI) # D-4 : FROM "(B)(4)" TO " (B)(4)." THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 09/23/2024. AN INVESTIGATION WAS CONDUCTED ON 10/03/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF CHARRED MATERIAL WAS OBSERVED ON THE INTACT HEATER WIRE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE CLEAR INTACT SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE, ADAPTER AND REFERENCE POWER SUPPLY AT LEVEL 3.0. THE DEVICE TURNED ON AND AN AUDIBLE SOUND WAS HEARD WHEN ACTIVATING THE TOGGLE. THE DEVICE PASSED THE PRE-CAUTERY TEST. IT PRODUCED VISIBLE STEAM AND HEAT DURING TEN (10) 3-SECOND ACTIVATIONS. THE DEVICE WAS TESTED FOR THE SAFETY SHUT DOWN SYSTEM AS THE DEVICE WOULD TURN ON, AND PRODUCED VISIBLE STEAM. AN ACTIVATION AND TRANSECTION CAPABILITY TEST WAS PERFORMED OVER FOUR (04) REPETITIONS USING "MAX LIFE TEST METHOD STM2048073 REV AA. THE DEVICE SUCCESSFULLY TRANSECTED TISSUE FIVE (5) TIMES. THE JAWS WERE GENTLY CLEANED OF DEBRIS AND CHAR WITH A SALINE AND GAUZE PAD AS INDICATED IN THE DIRECTION FOR USE (CV000008979). A TEMPERATURE AND RESISTANCE TEST WAS CONDUCTED TO EVALUATE THE DEVICE FUNCTION PER HEMOPRO 2 FINAL TEST 90523436 REV W. THE RESISTANCE VALUE WAS MEASURED AT .67 OHMS WHICH IS WITHIN SPECIFICATION. THE DEVICE PASSED THE TEMPERATURE MEASUREMENTS TEST. THE DISPLAYED TEMPERATURE INCREASED AND TURNED GREEN WITHIN THE 2 SECOND SPECIFIED TIMEFRAME. THE DISPLAYED TEMPERATURE DECREASED ONCE THE TOGGLE SWIVEL WAS RELEASED. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "FAILURE TO CUT¿ WAS NOT CONFIRMED. THE LOT # 3000322257 HISTORY RECORD REVIEW WAS COMPLETED. THERE WAS (ONE) NCMR , REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. [NCMR #17985-TWO COMPLAINTS (B)(4) WERE REPORTED BECAUSE THERE WAS NO MOVEMENT OF THE HOT AND COLD JAWS WHEN THUMB TOGGLE ON HP2 TOOL(C-VH-4000) WAS MOVED TO THE FULLY OPEN AND CLOSED POSITION. ]. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURES.
TRACKWISE ID#: (B)(4). UPDATED SECTIONS: B-4,,,G-3, G-6, H-2,H-6,H-11
TW ID# (B)(4); E1 EVENT SITE NAME EXCEEDED CHARACTER LIMITATIONS: (B)(6); 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.
N/A.
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 WOULD NOT "BURN" DIVIDE BRANCHES COMPLETELY. HARVESTER WENT THROUGH THE OVERHEATING PROTOCOL, CHANGED CORDS AND THE ISSUE PERSISTED. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2521438 | VASOVIEW HEMOPRO 2 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-4000 | 3000322257 | 00607567700406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | UNKNOWN. |