MAUDE Adverse Event Report: INVUITY, INC SINGLE FIBER OPTIC CABLE, 10FT, PINK

Model Number	FC1SP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During evaluation, it was noted that broken fibers were present throughout the cable.Additionally, the cable exhibited a concentrated number of broken fibers which indicates mishandling of the cable.The concentration of broken fibers led to an elevated temperature.Invuity's ifu clearly states to handle the cables with care and not to coil the cables tighter than six (6) inches.
Event or Problem Description
It was reported during a hip replacement procedure, the fiber optic cable may have been placed on the drape of the patient.During use, the temperature of the fiber optic cord felt hot and left a burn mark on the drape.The case was completed without incident or product malfunction.There was no patient injury involved.

• Brand Name: SINGLE FIBER OPTIC CABLE, 10FT, PINK
• Common Device Name: SINGLE FIBER OPTIC CABLE, 10FT, PINK
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• MDR Report Key: 7784680
• Report Number: 3011394215-2018-00006
• Device Sequence Number: 2217903
• Product Code: FST
• UDI-Device Identifier: 00816728020202
• UDI-Public: 00816728020202
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 07/17/2018

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: No Information
• Device Model Number: FC1SP
• Device Catalogue Number: FC1SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1