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

Catalog Number 0703315012

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

It was reported that after a medical procedure, it was noted that the diathermy t-loop wire was broken.It was also reported that there were no delays and there were no adverse consequences as a result of this event.

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded.

Event Description

It was reported that after a medical procedure, it was noted that the diathermy t-loop wire was broken.It was also reported that there were no delays, no medical intervention and no adverse consequences as a result of this event.

Manufacturer Narrative

H6: the quality investigation is complete.

• Brand Name: LOOP T-BAR ELECTRODE W15 D12
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15493527
• MDR Text Key: 301573283
• Report Number: 0001811755-2022-00047
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 37613327297950
• UDI-Public: 37613327297950
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0703315012
• Device Lot Number: 2125021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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