MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOOP T-BAR ELECTRODE W20 D15; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703320015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be filed once the quality investigation is complete.Device discarded, photograph provided.
Event or Problem Description
It was reported that during a procedure, the t-loop wire broke.It was also reported that the procedure was completed successfully.No further information was provided.
Additional Manufacturer Narrative
B5: updated event details.H3: photograph provided.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure, the t-loop wire broke.It was also reported that the procedure was completed successfully.It was subsequently reported that there was no clinically significant delay and no adverse consequences as a result of this event.

• Brand Name: LOOP T-BAR ELECTRODE W20 D15
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15704388
• Report Number: 0001811755-2022-00061
• Device Sequence Number: 17797227
• Product Code: GEI
• UDI-Device Identifier: 37613327297899
• UDI-Public: 37613327297899
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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 Expiration Date: 05/20/2023
• Device Catalogue Number: 0703320015
• Device Lot Number: 2021051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• 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