MAUDE Adverse Event Report: INVUITY, INC PHOTONBLADE

Model Number	PB1
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During a breast biopsy procedure, the physician noted a small amount of energy discharge coming from the shaft of the device.This resulted in a small burn (<1 mm) at the opening of the incision.The doctor removed the affected tissue and closed the incision.

• Brand Name: PHOTONBLADE
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 6679528
• Report Number: 3011394215-2017-00007
• Device Sequence Number: 1972394
• Product Code: GEI
• UDI-Device Identifier: 00816728020158
• UDI-Public: 00816728020158
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention