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

Catalog Number 0703320015

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure the t-loop electrode burnt out.

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device not available for return.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a procedure the t-loop electrode burnt out.This is event #2 of 3.

• Brand Name: LOOP T-BAR ELECTRODE W20 D15
• Type of Device: 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18152992
• MDR Text Key: 329331536
• Report Number: 0001811755-2023-00232
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 37613327297899
• UDI-Public: 37613327297899
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0703320015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1