MAUDE Adverse Event Report: INVUITY, INC PHOTONBLADE

Model Number	PB1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Invuity performed a follow up with the physician.The patient was released with no extended stay and there were no post-surgical complications.The lot number was not available; however, only two lots have been shipped to this hospital.Both batch records were reviewed and there were no manufacturing related issues identified.All devices are 100% functionally tested in-line prior to final release.This is the only reported incidence for this type of complaint.The reported product was returned for evaluation, and it was confirmed that the locking mechanism was in two main halves with a third smaller piece missing.The root cause for the fracture could not be determined.
Event or Problem Description
Toward the end of a bi-lateral nipple sparing mastectomy, the collar that locks/unlocks the telescoping shaft broke.Two main halves were retrieved immediately and a third smaller piece could not be accounted for.The surgeon did an examination of the surgical cavity and did not see a third piece.

• Brand Name: PHOTONBLADE
• Common Device Name: PHOTONBLADE
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 7252965
• Report Number: 3011394215-2018-00002
• Device Sequence Number: 16447506
• Product Code: GEI
• UDI-Device Identifier: 00816728020158
• UDI-Public: 00816728020158
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/09/2018

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 Model Number: PB1
• Device Catalogue Number: PB1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1