MAUDE Adverse Event Report: INVUITY, INC. PHOTONGUIDE, WIDE/FLAT; LIGHT, SURGICAL, CARRIER

Model Number	Wide / Flat
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Bulb melted during procedure.Fda safety report id# (b)(4).

• Brand Name: PHOTONGUIDE, WIDE/FLAT
• Common Device Name: LIGHT, SURGICAL, CARRIER
• Manufacturer (Section D): INVUITY, INC. ; san francisco CA 94107
• MDR Report Key: 11010486
• Report Number: MW5098341
• Device Sequence Number: 17097157
• Product Code: FSX
• UDI-Device Identifier: 00816728020646
• UDI-Public: (01)00816728020646
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: Wide / Flat
• Device Catalogue Number: 104015
• Device Lot Number: AB20013104
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR