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

Model Number	E3305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
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 adenoidectomy, an area of insulation on the suction bovie electrode was seen to have failed.The surgeon examined the patient¿s surgical sight and noticed an area of approximately 4.6 mm adjacent to the surgical side that had unintentional ablation/cauterization caused by the failed insulation.Patient¿s procedure completed with new suction cautery wand.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned.A picture was provided by the customer for analysis.The picture showed a burn mark on the tube of the device.The reported condition was confirmed.The investigation found a burn mark on the tube of the device.Without the physical device, could not determine the cause of the reported condition.The investigation could not determine the root cause of the customer's report.The customer is advised to return the incident device so a complete evaluation can be performed.If information is provided in the future, a supplemental report will be issued.

• 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: 8893942
• Report Number: 3006451981-2019-00165
• Device Sequence Number: 18911777
• Product Code: GEI
• UDI-Device Identifier: 20884521039077
• UDI-Public: 20884521039077
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 05/12/2024
• Device Model Number: E3305
• Device Catalogue Number: E3305
• Device Lot Number: S9EE005X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR