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

Model Number	E2505-10FR
Medical Device Problem Codes	Device Alarm System (1012); Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: vlft10gen, vlft10gen ft series energy platformx1 (serial#: unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during tonsillectomy procedure, the device failed to produce coagulation therapy and was required to coagulate for tonsil removal.They held on to device using alternative to complete the procedure.The patient was readmitted five days post-op for additional surgery to resolved tonsil hemorrhage.
Event or Problem Description
It was reported that during tonsillectomy procedure, the device failed to produce coagulation therapy and was required to coagulate for tonsil removal.It was removed and opened new set, unsuccessful, removed adapter and switched to alternative adapter to complete the procedure.The patient was readmitted five days post-op for additional surgery to resolved tonsil hemorrhage.
Additional Manufacturer Narrative
Additional information: b5, e1 (first name, last name and phone number), e3, e4 (email), g3.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: b5, d3 (mfr name and address), d4 (expiration date, lot#, udi#), d9, g3, h4, h6 (fdd).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during tonsillectomy procedure, the suction coagulation device was connected to universal adapter but failed to produce coagulation therapy and alarming occurred.The device was repositioned but it was still the same.A new package was opened and connected it to the adapter but it also did not work.It was then held by a staff member without the adapter to the monopolar port, which resolved the issue.The patient was readmitted five days post-operation for additional surgery to resolved tonsil hemorrhage.
Additional Manufacturer Narrative
Additional information: g3, h6.Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22504859
• Report Number: 1717344-2025-00919
• Device Sequence Number: 8788810
• Product Code: GEI
• UDI-Device Identifier: 20884521038957
• UDI-Public: (01)20884521038957(17)270825(10)S22HE015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: S22HE015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 08/20/2025; 08/28/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/25/2025; 08/27/2025; 09/02/2025
• Date Device Manufactured: 08/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male