MAUDE Adverse Event Report: INVUITY, INC INVUITY, INC.; PHOTONBLADE

Model Number	PB1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up information was requested, but no new details have been provided as of 01/05/2018.
Event or Problem Description
It was reported to an invuity representative on (b)(6) 2017 that during a battery replacement of an icd the insulation of a lead was accidentally melted.

• Brand Name: INVUITY, INC.
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 7170446
• Report Number: 3011394215-2017-00010
• Device Sequence Number: 1826439
• Product Code: GEI
• UDI-Device Identifier: 00816728020158
• UDI-Public: 00816728020158
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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 Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1