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

Catalog Number C-VH-3000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 09/06/2016

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 wires became dislodged while the jaws were being cleaned outside of the body.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.Tissue and charred material was observed on the jaws.The silicone insulation on the cold jaw was completely detached from the jaw.Traces of silicon insulation remained on the jaw.The detached silicon insulation was returned.No other visual defects were observed.Based on the return condition of the device and the evaluation results, the reported complaint is not confirmed for the reported failure mode "bent wire" but is confirmed for the analyzed failure mode "peeled insulation".Specific actions for the analyzed failure mode are being maintained and documented in maquet's corrective and preventive action (capa) system.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro wires became dislodged while the jaws were being cleaned outside of the body.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 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: 6001766
• MDR Text Key: 57182111
• Report Number: 2242352-2016-00958
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2017
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25126680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2016
• 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