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

Catalog Number C-VH-3000

Device Problems Thermal Decomposition of Device (1071); Crack (1135); Melted (1385)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(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, vasoview hemopro cautery cracked and melted.Nothing broke off, nothing fell in patient.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: date received by manufacturer, adverse event, if follow-up, what type?, device evaluated by manufacturer, event problem and evaluation codes, additional manufacturer narrative and/or corrected data.Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical usage and evidence of blood were observed.Tissue and charred buildup was observed at the jaws.The heater wire was observed to be slightly flexed at the center of the hot jaw.The heater wire remained attached at the tip and base of the hot jaw.The silicone insulation was observed to be peeled on the back of the cold jaw and still attached to the jaw.There was an evidence that silicone insulation on both jaws were charred.No other visual defects were observed.Based on the condition of the returned device and the results of the evaluation, the reported failure "thermal decomposition " was not confirmed and the analyzed failure "peeled" and "material twisted/bent wire" were confirmed.An electrical evaluation was conducted.A pre-cautery test as was performed per the instruction for use (ifu cv000006799) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam during several activations over a period of 10 minutes and shut off when the toggle was released.The pre-cautery test was repeated 5 times while the cable connections were manipulated with no observed failure.The handle was opened to evaluate the internal components.No visible defects were observed to the toggle.The switch was examined under microscopy.No residue or contamination was seen on the switch.We were unable to observe any electrical issues for the complaint unit during our testing.Based on the return condition of the device and the evaluation results, the reported failure mode "thermal decomposition of device" was not able to be confirmed and was confirmed for the analyzed failure modes "peeled jaw" and "material twisted/bent".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro cautery cracked and melted.Nothing broke off , nothing fell in patient.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 8582025
• MDR Text Key: 144266522
• Report Number: 2242352-2019-00523
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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 Expiration Date: 02/28/2020
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25145057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR