MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVAC 70 XTRA COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EICA5872-01

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Disposable instrument (evac 70 xtra) did not work properly.Plasma wand.The disposable instrument (evac 70 xtra) did not work properly at the beginning of the case.The instrument was removed and replaced during the case.No harm was caused to the patient.The staff removed the faulty equipment from the field and replaced it.They ensured the safety of the patient.Item was not sequestered for return.Unable to confirm further details on the item.

• Brand Name: EVAC 70 XTRA COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 7482769
• MDR Text Key: 107242886
• Report Number: 7482769
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2018

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: Unknown
• Device Model Number: EICA5872-01
• Device Catalogue Number: EICA5872-01
• Device Lot Number: 2003600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR