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

Model Number	PB1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the coating began to chip off when wiping off the blade after using a dry towel then a wet towel.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.

• 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: 9733729
• Report Number: 0001811755-2020-00525
• Device Sequence Number: 3320363
• Product Code: GEI
• UDI-Device Identifier: 00816728021094
• UDI-Public: 00816728021094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: Health Professional
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1