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

Catalog Number 7210812

Device Problem Intermittent Energy Output (4025)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during an arthroscopy, the vulcan generator stopped working, the machines reset to default setting multiple times during the procedure, they were turning on and off intermittently.Surgery was completed after a delay greater than 30 minutes, with a back-up device instead.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information: two serials numbers were provided because it is unknown which of them contributed to the delay greater than 30 minutes.

Event Description

It was reported that, during an arthroscopy, two (2) vulcan generator stopped working, the machines reset to default setting multiple times during the procedures, they were turning on and off intermittently.Surgery was completed after a delay greater than 30 minutes, with a back-up device instead.No further complications were reported.

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.Visual inspection observed impact/drop damage to the unit.The units bezel and lid are damaged, and the back of the unit is pushed in and bent, bending the power plug housing.Functional evaluation revealed on power up, the units nem led does not change from red but still allows the unit to output voltage for a short time, until the unit presents an rf disabled check return electrode error during activation and resets the units power with power reset on and off.Opening the device internals are bent in multiple locations from impact/drop damage and some liquid residue is noticed on the floor of the unit near the nem port.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event, include exposing the unit to liquids or improper cleaning and sterilization methods, and an impact event to the device inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15936680
• MDR Text Key: 305949260
• Report Number: 1643264-2022-00454
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885554019919
• UDI-Public: 885554019919
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K991140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1