MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PHOTONBLADE WITH ADAPTIVE SMOKE EVACUATION; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number	PB2SE
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mastectomy, the coating on the photon blade flaked off.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a mastectomy, the coating on the photon blade flaked off.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: PHOTONBLADE WITH ADAPTIVE SMOKE EVACUATION
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15874599
• Report Number: 3015967359-2022-02352
• Device Sequence Number: 5362213
• Product Code: GEI
• UDI-Device Identifier: 00816728021261
• UDI-Public: 00816728021261
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191583
• 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): 03/01/2023

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 Model Number: PB2SE
• Device Catalogue Number: PB2SE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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