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	Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that prior to a procedure it was observed that there was a hair inside the sterile packaging for the e-sep pencil.There was no patient impact, no medical intervention and no adverse consequences.
Event or Problem Description
It was reported that prior to a procedure it was observed that there was a hair inside the sterile packaging for the e-sep pencil.There was no patient impact, no medical intervention and no adverse consequences.
Additional Manufacturer Narrative
Additional information: h6: the quality investigation is complete.D4: full udi added.Correction: h6: device code updated based on the complaint investigation.

• 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; 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: 19484396
• Report Number: 3015967359-2024-01121
• Device Sequence Number: 12789768
• Product Code: GEI
• UDI-Device Identifier: 07613327117202
• UDI-Public: (01)07613327117202(17)260317(10)64354864
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/17/2025

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: 64354864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 01/17/2025
• 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