MAUDE Adverse Event Report: INVUITY, INC PHOTONSABER F; PHOTONSABER F, 8FR STANDARD, TEARDROP

Model Number	PSF08ST
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While being held by the (b)(6), the lighted suction started smoking and the plastic tip melted.It was removed from the surgical field and replaced; there was no impact to the patient.The device was not returned for evaluation; the initial report was discovered via search of the maude database listings.

• Brand Name: PHOTONSABER F
• Common Device Name: PHOTONSABER F, 8FR STANDARD, TEARDROP
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 8201454
• Report Number: 3011394215-2018-00008
• Device Sequence Number: 1901168
• Product Code: JOL
• UDI-Device Identifier: 00816728020134
• UDI-Public: 00816728020134
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: Health Professional
• Device Expiration Date: 12/08/2019
• Device Model Number: PSF08ST
• Device Catalogue Number: PSF08ST
• Device Lot Number: 17120802
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1