MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL VULCAN GENERATOR CE MARK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 7210812S

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the vulcan generator does not power on.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Rf generator failed to power up.Cause of power failure is a defective power supply.Unit passed functional testing after a known good power supply was installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.

• Brand Name: SVCE REPL VULCAN GENERATOR CE MARK
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10992573
• MDR Text Key: 220962598
• Report Number: 1643264-2020-02090
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 03596010542182
• UDI-Public: 03596010542182
• Combination Product (y/n): N
• PMA/PMN Number: K991140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

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 Model Number: 7210812S
• Device Catalogue Number: 7210812S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 11/21/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 02/10/2021
• Supplement Dates FDA Received: 01/17/2021; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1