MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-4000

Device Problems Poor Quality Image (1408); Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, plastic tip was all spotty and visualization was poor.The case was not delayed.A new kit was opened to complete the case.No harm or adverse effect to the patient.

Event Description

N/a.

Manufacturer Narrative

Trackwise (b)(4).The device was returned to the factory for evaluation on 06/21/2023.An investigation was conducted on 06/28/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were spots observed on the dissection tip.A clear image was unable to be obtained.The image was observed to be spotty.Based on the results of the evaluation, the reported failures "poor quality image" and "particulates" were confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000316987 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 HEMOPRO 2
• Type of Device: 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: 17290617
• MDR Text Key: 318780603
• Report Number: 2242352-2023-00555
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000316987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG