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

Catalog Number	PB2SE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation if device is available for return.
Event or Problem Description
It was reported that during a surgical procedure, part of a photon blade with adaptive smoke evacuation broke off.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
D9: it was initially reported the product was available for evaluation, the customer subsequently reported that the product is not available.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, part of a photon blade with adaptive smoke evacuation broke off.The procedure was completed successfully without a clinically significant 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18132401
• Report Number: 3015967359-2023-02462
• Device Sequence Number: 18071356
• Product Code: GEI
• UDI-Device Identifier: 00816728021261
• UDI-Public: 00816728021261
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/20/2023

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 Expiration Date: 04/24/2025
• Device Catalogue Number: PB2SE
• Device Lot Number: F23/D24-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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