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

Model Number VH-4000

Device Problems Intermittent Continuity (1121); Intermittent Loss of Power (4016)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (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.

Event Description

The hospital reported that vasoview hemopro 2 bipolar diathermy attachment was not functioning correctly.It would only intermittently work.The power unit was replaced, and then the lead was replaced.These did not fix the problem, so a second box was opened.There was no harm to patient.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: h6--medical device ¿ problem code corrected from "(b)(4)".

Event Description

The hospital reported that during an endoscopic vessel harvesting procedure, vasoview hemopro 2 bipolar diathermy attachment was not functioning correctly.It would only intermittently work.The power setting was 3.The power unit was replaced, and then the 7mm scope and power source extension lead was replaced.These did not fix the problem, so a second box was opened and the issue resolved.There was a procedural delay of approximately 10 min for troubleshooting steps.There was no harm to patient.

Manufacturer Narrative

Tw # (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).Updated sections: b4, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation 02/22/2024.An investigation was conducted on 02/28/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed on the cannula.There were no visual defects observed on the intact cannula or the intact c-ring.There were no visual defects observed on the intact harvesting device.There were no visual defects observed on the intact heater wire.The clear silicone insulation on both the cold and hot jaws.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply at level 3.0.The device did turn on and an audible sound was heard when activating the toggle, however, intermittent power was observed when manipulating the toggle to activate the device.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam, however there was intermittent power as the device was activated.An activation and transection capability test was performed over four (04) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (b)(4) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.69 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released.Based on the returned condition of the device as well as the evaluation results, the reported failure "intermittent continuity" was confirmed.An engineer evaluation was conducted on 03/12/2024.Hemopro2 tool failed the pre-cautery test.The heating element in the primary jaw of the complaint device did not heat up and the hemopro power supply did not beep during the precautery test indicating that electrical current was not flowing through the complaint device.It was also observed during the pre-cautery test, that the normal clicking sound made by the switch¿s internal contacts when they close together did not occur which is not normal.The handle of the hemopro 2 tool complaint device was opened to further investigate the device¿s switch (part# rm7001322).It was visually observed that the switch lever was bent downwards.The downward bend in the switch lever, resulted in the end of the switch lever not being in contact with the stop tab in the handle, which is not normal.Using digital calipers, bmram id# (b)(4), the switch¿s operating point (o.P.) was measured to be 8.28 mm which is 0.82 mm below the switch¿s specification nominal o.P.Of 9.10 mm.The 8.28mm o.P.Measurement was also outside the switch¿s operating point specification tolerance of 9.10 0.80 mm.The downward bend in the switch lever was preventing the switch lever from traveling the amount needed to actuate the switch ¿on¿.Thereby preventing electrical energy from going to the heating element in the complaint device see attached engineer evaluation memo.Based on the returned condition of the device as well the investigation results as well as the engineer evaluation , the reported failure "intermittent continuity" was confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot #3000335669 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: 18382289
• MDR Text Key: 331190278
• Report Number: 2242352-2023-01061
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2024

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: 3000335669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/19/2024; 04/10/2024; Not provided
• Supplement Dates FDA Received: 03/14/2024; 04/30/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7MM SCOPE.; POWER SUPPLY, LEAD.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 84 KG