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

Model Number VH-4001

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

The hospital reported that during preparation for an endoscopic vessel harvesting procedure while inserting the jaws of vasoview hemopro 2 (w/vasoshield) with tips closed and up, one side of the jaws metal bent and was damaged making the device unusable.A new device was opened to complete the procedure.There was no procedural delay.There was no patient harm.There were no other issues.

Manufacturer Narrative

(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.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 03/26/2024.An investigation was conducted on 3/26/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.A microscopic inspection was conducted.The clear silicone insulation of both the hot and cold jaws was observed to be intact with no visual defects.The heater wire was observed to be twisted and flexed away from the base of the hot jaw and detached from the tip of the jaw.Based on the returned condition of the device and investigation results, the reported failure "material twisted/bent; wire" was confirmed.The lot # 3000358120 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.

Event Description

N/a.

• Brand Name: HEMOPRO 2 W/VASOSHIELD
• 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: 19011941
• MDR Text Key: 339108949
• Report Number: 2242352-2024-00309
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: 00607567700451
• 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
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000358120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1