MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO, OUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-3000-W
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Peeled/Delaminated (1454); Flare or Flash (2942)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, after the vasoview hempro (ous) vh-3000 is powered on, the current spark phenomenon occurs directly at the block clamp port, and then an open flame appears.It seemed the jaws burnt due to the open flame.Yes, the device remained activated.The medical staff cut off the power in time, so there was no accident.And then the doctor used another new one to complete the surgery.
Additional Manufacturer Narrative
Tw id#: (b)(4).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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, after the vasoview hempro (ous) vh-3000 is powered on, the current spark phenomenon occurs directly at the block clamp port, and then an open flame appears.It seemed the jaws burnt due to the open flame.Yes, the device remained activated.The medical staff cut off the power in time, so there was no accident.And then the doctor used another new one to complete the surgery.There was no delay for the procedure.There was no harm to the patient.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was not returned to maquet cardiac surgery for investigation; however photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact heater wire.Thermal decomposition was observed on both the gray cold and hot jaws, indicated by the brownish color on various parts on both the cold and hot jaw gray silicone insulation.The tip of the hot jaw was also observed to be peeled from the hot jaw.The gray silicone insulation on the cold jaw was not observed to be peeled.No flames were observed in the photographs.Based on the photographic evaluation, the reported failures "thermal decomposition of device" and peeled; delaminated; jaw" was confirmed.The reported failure "flash" was not confirmed.The lot # 3000293031 history record review was completed.There was an ncmr 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 failures.H3 other text : device discarded.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW HEMOPRO, OUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 18184354
• Report Number: 2242352-2023-00962
• Device Sequence Number: 7611021
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: VH-3000-W
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 3000293031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 12/29/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/12/2023; 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female