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

Model Number	E2505-10FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/12/2018
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 tonsillectomy, adenoidectomy and uvulectomy, the generator would not have activated if it did not sense a complete circuit with the patient return electrode.The generator delivered energy, but we they unsure how the inadvertent burns were caused on the corners' of the patient's mouth.Patient experienced two electrocautery 2nd degree burns on the corners of mouth with less than.25cm in size.Patient burn was noticed at the end of the procedure when the mouth gag was removed.The account had (3) different lot numbers on their shelf, so the pencil that was used must have originated from one of the 3 lots specified in the report.They tested the esu generator with my own valleylab rem pad and it performed regularly, including the quality-contact monitoring system.Topical ointment and oral pain medication for patient comfort.They completed the procedure using a monopolar electrocautery.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product 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.The investigation found no defects in the device.Continuity was checked between the electrode tip and the plug with satisfactory results.The device was plugged into a generator and activated with satisfactory results.The device passed hipot testing.The investigation found the device to function normally and within specifications.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: 8234141
• Report Number: 3006451981-2019-00009
• Device Sequence Number: 11198968
• Product Code: GEI
• UDI-Device Identifier: 20884521038957
• UDI-Public: 20884521038957
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 02/08/2019

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: 06/22/2023
• Device Model Number: E2505-10FR
• Device Catalogue Number: E2505-10FR
• Device Lot Number: S8FE013X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 92