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

Catalog Number C-VH-4000

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

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

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

(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 during an endoscopic vein harvesting procedure using vasoview hemopro 2 they noticed power cutting out to the hemopro.They changed cables but the problem kept occurring.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).A lot history record review was completed for lots 25140406, 25140783, and 25140896 the last 3 lots shipped to the account prior to the event date.There was no ncmr's recorded in the lot history.The hp2 device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.Specks of blood were observed on the harvesting tool handle and toggle.The heater wire was slightly flexed away from the center of the hot jaw with no detachment.The wire remained in place at the tip and base of the hot jaw.No other failures were observed.The device was evaluated for toggle function.The toggle did not operate as expected.When actuating the toggle on the handle of the reported device to the power on position multiple times, it was found that intermittently, the heating element in the jaws of the device would not heat up.In addition, it was also observed that when the heating element in the jaws of the device did not heat up, that also the normal clicking sound made by the switch's internal contacts did not occur.The device was evaluated for electrical function.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply vh-3010 at level 3.0.The device did not pass the pre-cautery test; it intermittently produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.An engineering evaluation was conducted that identified the root cause of the intermittent continuity failure.To check the electrical continuity in the device, the harvesting handle was opened to further investigate the device's switch.The device switch was evaluated and it was observed to have an operating point (o.P) that is lower than the normal 8.3 mm, which was measured to be 8.17 mm.It is determined that the hp2 switch, which was activating below manufacturer's minimum o.P.Specification, is the root cause of the complaint.Based on the results of the evaluation, the reported failure mode ¿intermittent continuity¿ and analyzed failure mode ¿material twisted/bent; jaw¿ were confirmed.Due to no lot information provided.We are unable to obtain a c of c and a dhr.Specific actions for the analyzed failure "material twisted/bent; wire" are being maintained and documented under maquet's failure investigation report (fir) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2 they noticed power cutting out to the hemopro.They changed cables but the problem kept occurring.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8406338
• MDR Text Key: 138511119
• Report Number: 2242352-2019-00278
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

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 Catalogue Number: C-VH-4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/09/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1