MAUDE Adverse Event Report: INVUITY, INC INVUITY, INC.; PHOTONBLADE

Model Number	PB1
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Sparking (2595)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During a lumpectomy procedure, the physician noticed that the distal tip of the telescoping waveguide felt hot.The physician examined the incision area and noticed a burn near the peri-areola region that required a surgical intervention.

• Brand Name: INVUITY, INC.
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 6614502
• Report Number: 3011394215-2017-00003
• Device Sequence Number: 712819
• Product Code: GEI
• UDI-Device Identifier: 00816728020158
• UDI-Public: 00816728020158
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/17/2017

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 Expiration Date: 11/03/2017
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: 17040307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/06/2017
• 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: Other