MAUDE Adverse Event Report: MAQUET CV VASOVIEW 7 XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3200

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2018

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 preparation for an endoscopic vein harvesting procedure, one of the vasoview 7 xb bisector bipolar ligation forceps was bent upward.A replacement device was used to complete the procedure.No patient involvement.

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.One electrode was observed to be bent at the base of the electrode.There were no non-conformities or visual defects observed to the other electrode or the bisecting blade.Based on the return condition of the device, the reported failure "bent electrodes" was confirmed.The shop floor paperwork was reviewed.All the test results meet the specifications and requirements.There were no non-conformities observed.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, one of the vasoview 7 xb bisector bipolar ligation forceps was bent upward.A replacement device was used to complete the procedure.No patient involvement.

• Brand Name: VASOVIEW 7 XB
• 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: 7501089
• MDR Text Key: 107975414
• Report Number: 2242352-2018-00449
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041981
• 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: 05/09/2018

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: 01/22/2020
• Device Catalogue Number: C-VH-3200
• Device Lot Number: 25136660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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