MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E3310
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned products met specification as received.Visual inspection found no defects.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Visual inspection found the tube tip showed no on sign of heat damage.The device was activated at 60w.No flame or abnormal effects was noted.The device passed hipot testing.The investigation found the device to function normally.The instructions for use (ifu) warns: the sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times: when using electrosurgery in the same room with gases or flammable substances, prevent pooling of fluids and the accumulation of gases under surgical drapes or near the surgical site.Tissue buildup (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen-enriched environments, such as in throat or mouth procedures.Eschar plus high oxygen may create embers.Keep the electrode clean and free of all debris.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, device distal tip had a flame.Product was immediately removed from the surgical field and a new device was opened and used with no issues.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, device distal tip had a flame.Product was immediately removed from the surgical field and a new device was opened and used with no issues.The flame went out when the device was deactivated.There was no patient injury or burn.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 9149340
• Report Number: 3006451981-2019-00192
• Device Sequence Number: 2928915
• Product Code: GEI
• UDI-Device Identifier: 20884521039091
• UDI-Public: 20884521039091
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2024
• Device Model Number: E3310
• Device Catalogue Number: E3310
• Device Lot Number: S9FE005X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1