MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-3200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise 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.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 7 xb bisector malfunctioned (separated from the shaft).There were no parts of the device that fell into the patient, all was accounted for.Power setting unknown.A second device was used to complete the procedure.There was no delay, or harm to the patient reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise id (b)(4) updated sections: b4, d10,g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation 09/20/2023.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood were observed on bisectors and shaft.Evidence of charred material was observed on the blade and bisectors.The bisectors and blade were observed to be intact with no visual defects.He hub was observed to have separated from the flexible shaft, exposing the inner contents of shaft, which contained evidence of blood.An investigation was conducted on 09/22/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.Evidence of charred material was observed on the blade and bisectors.The bisectors and blade were observed to be intact with no visual defects.The hub was observed to have separated from the flexible shaft, exposing the inner contents of shaft, which contained evidence of blood.No evidence of adhesive was observed on the shaft.The hub was able to be pushed back into the shaft.Based on the photographic inspection, returned condition of the device, and investigation results, the reported failure "material separation" was confirmed.The lot # 3000310058 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.

• Brand Name: VASOVIEW 7XB
• 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: 17779900
• Report Number: 2242352-2023-00788
• Device Sequence Number: 5492441
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2023

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: 04/11/2025
• Device Model Number: VH-3200
• Device Catalogue Number: VH-3200
• Device Lot Number: 3000310058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 71 KG