MAUDE Adverse Event Report: INVUITY, INC PHOTONBLADE

Model Number	PB1
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned and an investigation was performed.On initial evaluation with the device connected to an esu, the reported problem was unable to be replicated.The activation button was pushed and a tone was emitted from the esu; when the button was released, the tone stopped.Upon further investigation, an aggressive force was applied which wedged the button and caused it to remain active.The tone was emitted from the esu.After the button was repositioned, the tone from the esu remained active.Batch record review was performed for this lot and there were no manufacturing-related issues identified.
Event or Problem Description
During a case the photonblade remained active after the button was released.There was no patient injury.The device was unplugged and the case was completed using a different device.

• Brand Name: PHOTONBLADE
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 7520882
• Report Number: 3011394215-2018-00003
• Device Sequence Number: 1176194
• Product Code: GEI
• UDI-Device Identifier: 00816728020158
• UDI-Public: 00816728020158
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/19/2018

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: 06/04/2018
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: 17110404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1