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

Model Number	E2505-10FR
Medical Device Problem Codes	Failure to Deliver Energy (1211); Separation Problem (4043)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, the surgeon bovied tissue again where tissue had adhered on previous seal and was not hemostatic after first application of energy.The surgeon was stating that in two cases the bovie seems to be sticking to tissue in tonsillectomies, when pulling bovie off of tonsils tissue was adhered and surgeon has to apply the bovie again due to sticking.Using with footpedal.Both incidents occurred with lot number in this report.Facility did not provide patient information for either incident of tissue sticking.Patient had tissue damage or unexpected tissue loss.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14568661
• Report Number: 3006451981-2022-00054
• Device Sequence Number: 5082549
• Product Code: GEI
• UDI-Device Identifier: 20884521038957
• UDI-Public: 20884521038957
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

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 Model Number: E2505-10FR
• Device Catalogue Number: E2505-10FR
• Device Lot Number: S1KE107X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/01/2022
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown