MAUDE Adverse Event Report: INVUITY, INC PHOTONBLADE

Model Number	PB1
Medical Device Problem Code	Out-Of-Box Failure (2311)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was treated with ointment.There was no further treatment or intervention required.An invuity representative was able to test the device at the user facility.The facility's or director and invuity representative connected the device to the esu and there was no audible sound.The cut button was pressed and released, and functioned as expected.The coag button was pressed and released, however the audible tone from the generator remained constant after releasing the button.The device was then disconnected from the esu and reconnected, and the audible tone activated.The device was not returned to invuity for full engineering evaluation.Therefore, the root cause could not be determined.A batch record review was performed for this lot and there were no manufacturing related issues identified.All devices are 100% functionally tested in-line prior to final release.This is the only reported incidence for this type of complaint.
Event or Problem Description
When the photon blade was initially connected to the generator, a solid audible tone was emitted by the esu.It was observed that the patient received two very minor burns.The case was completed using a second device.

• Brand Name: PHOTONBLADE
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 7245971
• Report Number: 3011394215-2018-00001
• Device Sequence Number: 143434
• Product Code: GEI
• UDI-Device Identifier: 00816728020158
• UDI-Public: 00816728020158
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/10/2018

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: Physician
• Device Expiration Date: 05/20/2018
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: 17102016R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1