MAUDE Adverse Event Report: Covidien llc Barrx; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	TTS-1100
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2026
Type of Reportable Event	Malfunction

• Brand Name: Barrx
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): Covidien llc; 3062 bunker hill lane; santa clara CA 94085 -402
• Manufacturer (Section G): Covidien llc; 3062 bunker hill lane; santa clara CA 94085 -402
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50564664
• Report Number: 3004904811-2026-00015
• Device Sequence Number: 10104828
• Product Code: GEI
• UDI-Device Identifier: 10884521581753
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: TTS-1100
• Device Catalogue Number: TTS-1100
• Device Lot Number: B000003458
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 02/19/2025
• 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