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

Model Number VASOVIEW HEMOPRO 2

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

The hospital reported that the vasoview hemopro 2 jaws were bent.The hemopro tip was bent such that when it exited the housing-oriented concave side toward the vein, it deflected at an angle that bisected the vein just past the c-ring (when the c-ring was extended to the index on the handle).No harm came from this.It was, however, difficult to use since they could not extend the hemopro jaws to their full length without risking major damage to the gsv.Since they have not had this issue before in my years of using the scope in any iteration, they assume it was bent at the table and not the factory.No added incisions or time.Finished case using new kit.No patient harm.

Manufacturer Narrative

Trackwise id (b)(6).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

(b)(4).The device was returned to the factory for evaluation on 11/10/2022.An investigation was conducted on 11/16/2022.A visual inspection was conducted.The harvesting device was returned inside the cannula.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties observed.There were no visual defects observed on the cannula or the intact c-ring.Signs of clinical use and evidence of blood was observed on the tip of the jaws.The heater wire was observed to be intact with no visual defects observed.The clear silicone insulation on both the cold and hot jaws was observed to be intact with no visual defects observed.Both the jaws were observed to be slightly bent forward from the base of the jaws.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/ bent jaw" was confirmed.The lot # 3000270295 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: 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: 15885582
• MDR Text Key: 306519056
• Report Number: 2242352-2022-00974
• 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: 12/06/2022

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: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000270295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.