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

Model Number VH-4000

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2023

Event Type  Injury  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cradle broke.The c-ring broke in half - the 2 supporting bars of the c-ring broke, and the c-ring end fell in to the harvesting tunnel.The loose piece was successfully retrieved with the hemopro as a grasper without additional incisions.The same device was used to complete the procedure.No procedural delay aside from a few minutes to retrieve the loose piece.No harm.

Manufacturer Narrative

Tw 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

N/a.

Manufacturer Narrative

Tw id# (b)(4).Specific actions for the reported mode is being maintained and documented under maquet's corrective and preventive action (capa) system.The device was returned to the factory for evaluation on 10/31/2023.An investigation was conducted on 10/31/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.The heater wire and clear silicone insulation of the jaws were observed to be intact with no visual defects.The c-ring was observed to be cut in half down the center with signs of melting near the flanking curved areas.The scope wash tubing and retention rib remained attached to the cannula.The scope wash tubing and the c-ring remained attached to the cannula due the presence of a retention rib.No pieces of the c-ring were observed to have detached from the device.Based on the returned condition of the device and the evaluation results, the reported failure "break; c-ring" was confirmed.The lot # 3000338512 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: 18068439
• MDR Text Key: 327353129
• Report Number: 2242352-2023-00919
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000338512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 178 KG