MAUDE Adverse Event Report: INVUITY, INC PHOTONBLADE

Model Number	PB1
Medical Device Problem Codes	Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up telephone conversation was held with the nurse manager that was involved in the case.The patient was released as planned; there was no additional intervention or extended stay required.The products involved are under evaluation with the hospital and are planned to be returned to invuity for investigation.Additionally, the hospital performed their own investigation and has since modified their esu setup when using two photonblades in the same procedure.
Event or Problem Description
A breast mastectomy/reconstruction procedure utilized two photonblade devices, which were performing as intended.During the middle of the procedure it was reported that one photonblade device, when activated, was observed to activate the secondary photonblade device.The secondary photonblade was replaced with a new photonblade and the procedure was completed without further incident.The physician noticed a minor burn near the axilla that required a minor surgical intervention.
Additional Manufacturer Narrative
The actual complaint devices were received and invuity attempted to replicate the described clinical setting based on information provided by the hospital: two esus located near the head of the bed, relative device handle and cable positions along each side of the bed.The reported behavior could not be reproduced.Further investigation was performed in an attempt to replicate the observation with more aggressive conditions, such as fluid ingress, higher energy settings, and intentionally wrapping one cable onto the other device.The reported behavior could not be reproduced.

• Brand Name: PHOTONBLADE
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 7895867
• Report Number: 3011394215-2018-00007
• Device Sequence Number: 16621732
• Product Code: GEI
• UDI-Device Identifier: 00816728020639
• UDI-Public: 00816728020639
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 08/22/2018

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: Health Professional
• Device Expiration Date: 04/20/2019
• Device Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: 18042001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHOTONBLADE (PB1) LOT 18052504 (EXP 25-MAY-2019)
• Outcome Attributed to Adverse Event: Required Intervention