MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB LS10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	VLLS10GEN
Medical Device Problem Codes	Energy Output Problem (1431); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, the handpiece was not working properly.The surgeon was not getting the seal he would normally expect to see and it was only sealing very minimally and looked faint.The machine gave the two-tone bleep and the sound emitted was faint, he said that the machine was not alarming.He requested a second handpiece be opened and this performed in a similar way initially until he decided to ask them to change the ls10 machine.On using a replacement machine, the second handpiece worked as normal.The unit was sent to electrical engineering department for checking.They tested with a new handpiece on damp tissue and said it all appeared ok and have put the machine back into circulation.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot#: 42830207x) unknown ligasur, unknown ligasure instrument.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 LS10
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21028188
• Report Number: 3006451981-2024-00164
• Device Sequence Number: 15748217
• Product Code: GEI
• UDI-Device Identifier: 10884521512801
• UDI-Public: 10884521512801
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: VLLS10GEN
• Device Catalogue Number: VLLS10GEN
• 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: 12/03/2024
• Initial Report FDA Received Date: 12/27/2024
• Date Device Manufactured: 01/12/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown