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

Model Number FC1SP

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

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 Description

During a hip replacement procedure, it was observed that the drape had a burn mark where the fiber optic cable had been resting upon it.There was no injury to the patient.

• Brand Name: SINGLE FIBER OPTIC CABLE, 10FT, PINK
• Type of Device: SINGLE FIBER OPTIC CABLE, 10FT, PINK
• Manufacturer (Section D): INVUITY, INC; 444 de haro st; san francisco CA 94107
• Manufacturer Contact: john kang ; 444 de haro st; san francisco, CA 94107 ; 4156552160
• MDR Report Key: 7755286
• MDR Text Key: 116559055
• Report Number: 3011394215-2018-00005
• Device Sequence Number: 1
• Product Code: FST
• UDI-Device Identifier: 00816728020202
• UDI-Public: 00816728020202
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1