MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SMOKE EVAC. PENCIL COATED PB,NON-STERILE; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Catalog Number	0703046002
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.
Event or Problem Description
It was reported that during an anorectoplasty, a flame was noticed coming from the e-sep tip when the electrode was changed.They didn't use the standard electrode that came in the bovie.They switched to the colorado needle electrode, a kirwan surgical product, when this needle was put in, it looked like a lighter every time they pushed coag.Usually they use a plug to eliminate gas coming out, they were unable to do so in this situation, every time they pressed coag, it flickered like a lighter.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during an anerectoplasty, a flame was noticed coming from the e-sep tip when the electrode was changed.They didn't use the standard electrode that came in the bovie.They switched to the colorado needle electrode, a kirwan surgical product, when this needle was put in, it looked like a lighter every time they pushed coag.Usually they use a plug to eliminate gas coming out, they were unable to do so in this situation, every time they pressed coag, it flickered like a lighter.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: SMOKE EVAC. PENCIL COATED PB,NON-STERILE
• 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: 18943320
• Report Number: 3015967359-2024-00524
• Device Sequence Number: 8405489
• Product Code: GEI
• UDI-Device Identifier: 37613327379489
• UDI-Public: 37613327379489
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143145
• 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): 09/23/2024

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 Catalogue Number: 0703046002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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