MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PHOTONBLADE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PB1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded.
Event or Problem Description
It was reported that during a procedure at the user facility the surgeon cut a lead while in use.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: PHOTONBLADE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10587859
• Report Number: 0001811755-2020-02474
• Device Sequence Number: 16849548
• Product Code: GEI
• UDI-Device Identifier: 00816728021094
• UDI-Public: 00816728021094
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K162053
• 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
• Report Date (Section B): 09/25/2020

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: No Information
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: 20021204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1