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

Model Number VASOVIEW HEMOPRO 2

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, for cauterization of ra bifurcated blood vessels, use 3 times (3) for cauterization for 5 to 10 seconds.From the impression that the degree of cauterization was weak, the (4th) cauterization was sufficient.They could not do it.They took it out of the body, wiped the tip of the jaw with a gauze soaked in water, and tried to reuse it.It wasn't enough.The evh surgeon was doctor, who is accustomed to hemopro2, and it was judged that the cauterization was insufficient in comparison with the normal use (cauterization).In addition, this time, after cauterization, carbonization (burnt) was seen at the tip of the jaw.The procedure was completed with the same device.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).The device was returned to the factory for evaluation on 10/01/2020.An investigation was conducted on 10/09/2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be intact, no visual defects were observed.The clear silicone insulation on both the cold and hot jaws was observed to be intact, no visual defects were observed.No thermal decomposition of the device was observed.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.An activation and transection capability test was performed over five (5) repetitions using "max life test method.The device activated and transected tissue five (5) times with no cautery failure observed.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value measured at 0.68 ohms which is within hemopro 2 final test specification.The device pass the temperature measurement test.The displayed temperature increase and turned ¿green¿ within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released.Based on the results of the evaluation, the complaint for the reported failures "electrical issue" and "thermal decomposition of device" was not confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2, for cauterization of ra bifurcated blood vessels, use 3 times (3) for cauterization for 5 to 10 seconds.From the impression that the degree of cauterization was weak, the 4th (4th) cauterization was sufficient.They could not do it.They took it out of the body, wiped the tip of the jaw with a gauze soaked in water, and tried to reuse it.It wasn't enough.The evh surgeon was dr, who is accustomed to hemopro2, and it was judged that the cauterization was insufficient in comparison with the normal use (cauterization).In addition, this time, after cauterization, carbonization (burnt) was seen at the tip of the jaw.The procedure was completed with the same device.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10619027
• MDR Text Key: 209549923
• Report Number: 2242352-2020-00852
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Device Lot Number: 25150926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1