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

Catalog Number	0703047000
Medical Device Problem Codes	Overheating of Device (1437); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H10: lot number of the device is unknown: full udi is not available.
Event or Problem Description
It was reported that during use in a procedure at the user facility, a cautery tip burned holes in drapes.It was reported that there were no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully, without a significant delay.
Additional Manufacturer Narrative
Additional information: h6: the quality investigation is complete.Correction: h6: device code updated based on complaint investigation.
Event or Problem Description
It was reported that during use in a procedure at the user facility, a cautery tip burned holes in drapes.It was reported that there were no adverse consequences and no medical intervention as a result of this event.It was further reported that the procedure was completed successfully, without a significant delay.

• Brand Name: ROCKER-SWITCH SMOKE EVAC PENCIL, COATED
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; carrigtwohill bus. & tech park; 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: 20516130
• Report Number: 3015967359-2024-02244
• Device Sequence Number: 7203950
• Product Code: GEI
• UDI-Device Identifier: 07613327173642
• UDI-Public: (01)07613327173642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143145
• 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): 12/11/2024

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: 0703047000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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