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

Model Number VH-4000

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

The hospital reported that vasoview hemopro 2 shears malfunctioned.There was no patient harm.

Manufacturer Narrative

(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.

Manufacturer Narrative

Trackwise (b)(4) the lot # 3000365389 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.H3 other text : device not returned.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section medical device ¿ problem code - h6 - from "3190" to "1198".

Event Description

The hospital reported that during an endoscopic vessel harvesting procedure, vasoview hemopro 2 shears malfunctioned and that it just stopped working.A new device was used to complete the procedure.There was a delay of 10-15 minutes.There was no patient harm.

• 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: 18885836
• MDR Text Key: 337445428
• Report Number: 2242352-2024-00237
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000365389
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/21/2024; 04/30/2024
• Supplement Dates FDA Received: 04/15/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 100 KG