MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP LOOP T-BAR ELECTRODE W15 D12; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703315012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure, the e-sep safeair electrode tip broke half way through.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure, the e-sep safeair electrode tip broke half way through.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: LOOP T-BAR ELECTRODE W15 D12
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 19498781
• Report Number: 3015967359-2024-01133
• Device Sequence Number: 7926066
• Product Code: GEI
• UDI-Device Identifier: 37613327297950
• UDI-Public: (01)37613327297950(17)250227(10)2210002
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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 Expiration Date: 02/27/2025
• Device Catalogue Number: 0703315012
• Device Lot Number: 2210002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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
• Patient Sex: Unknown