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

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 328065154
• Report Number: 3015967359-2023-02462
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00816728021261
• UDI-Public: 00816728021261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: PB2SE
• Device Lot Number: F23/D24-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1