MAUDE Adverse Event Report: INVUITY, INC INVUITY, INC; BIFURCATED FIBER OPTIC CABLE, 11.5FT

Model Number FC1B

Device Problem Use of Device Problem (1670)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

Post inspection, it was observed all four (4) cables exhibited broken fibers throughout the cable.One (1) of the four (4) returned cables exhibited a concentrated number of broken fibers at the bifurcation which indicates mishandling and abuse of the cable.The concentration of broken fibers led to an elevated temperature at the bifurcation of 64.0 c.Invuity's ifu clearly states to handle the cables with care and not to coil the cables tighter than six (6) inches.

Event Description

In a post surgery follow up, it was observed that the patient had a first degree burn on the chest.No hospitalization or further treatment was required for the patient.

• Brand Name: INVUITY, INC
• Type of Device: BIFURCATED FIBER OPTIC CABLE, 11.5FT
• 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: 6490282
• MDR Text Key: 72940808
• Report Number: 3011394215-2017-00001
• Device Sequence Number: 1
• Product Code: FST
• UDI-Device Identifier: 00816728020226
• UDI-Public: 00816728020226
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FC1B
• Device Catalogue Number: FC1B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• 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
• Treatment: EIKON LT; LUXTEC MLX; PHOTONGUIDE, NARROW/FLAT; PHOTONGUIDE, WIDE/FLAT; PHOTONSABER Y