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

Catalog Number C-VH-4000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 2 while attempting to cut the patients first venous branch, the harvester noticed that the cutting wire of the hemopro device was partially dislodged from the jaws.Customer opened another hemopro and the case was completed without any patient complications.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.The shaft was observed to be bent at the center of the shaft.The heater wire was flexed and twisted away from the hot jaw and detached at the tip but remained attached at the base.The silicon insulation was intact, no visual defects were observed.Based on the return condition of the device, the reported failure "bent wire" is confirmed as well as the analyzed failure "bent shaft" was confirmed.Specific actions for the reported failure mode 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, vasoview hemopro 2 while attempting to cut the patients first venous branch, the harvester noticed that the cutting wire of the hemopro device was partially dislodged from the jaws.Customer opened another hemopro and the case was completed without any patient complications.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7492381
• MDR Text Key: 107718446
• Report Number: 2242352-2018-00434
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25135783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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