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	08/29/2023
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 : device discarded.
Event or Problem Description
It was reported that the clamp that attaches the smoke tubing to the photon blade melted and fractured in 3 different procedures.It was further reported that for all 3 procedures, there was a total delay of 2 hours to retrieve the fragments and ensure no fragments remained in the surgical site.The procedure was completed successfully; no adverse consequences or medical intervention were reported.This mdr report is for the first event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that the clamp that attaches the smoke tubing to the photon blade melted and fractured in 3 different procedures.It was further reported that for all 3 procedures, there was a total delay of 2 hours to retrieve the fragments and ensure no fragments remained in the surgical site.The procedure was completed successfully; no adverse consequences or medical intervention were reported.This mdr report is for the first event.

• 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: 17800321
• Report Number: 3015967359-2023-01992
• Device Sequence Number: 20515120
• Product Code: GEI
• UDI-Device Identifier: 00816728021261
• UDI-Public: 00816728021261
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/17/2023

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 Catalogue Number: PB2SE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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