MAUDE Adverse Event Report: OMNIGUIDE, INC. OMNIGUIDE ELITE WAVE GUIDE FIBER; LASER FIBER

Catalog Number	322001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Laser fiber failed during use due to the laser energy heating the interior lumen of the fiber.This initiated a burn within the lumen which progressed from 45 cm from the distal tip to 122 cm from the proximal end.The burn blocked the flow of helium and lead to the failure of the device.Their fiber was examined by three different quality and engineering personnel however no creaks, holes, kinks or other damage was noted under magnification.There was a slight deformation felt at the site of the initial burn but the burn did not penetrate the outer jacket.The dfus note this may happen and to have a second fiber present in case of failure which the health care facility had in place.This is a known failure mode for the waveguide failure.
Event or Problem Description
Reportedly a small crack was found in the laser fiber during the procedure.The fiber was disconnected from the laser and another fiber utilized.The procedure was then completed.

• Brand Name: OMNIGUIDE ELITE WAVE GUIDE FIBER
• Common Device Name: LASER FIBER
• Manufacturer (Section D): OMNIGUIDE, INC.; 4 maguire road; lexington MA 02421
• MDR Report Key: 8830887
• Report Number: 3005350457-2019-09001
• Device Sequence Number: 13857370
• Product Code: GEX
• UDI-Device Identifier: 00894338002825
• UDI-Public: 00894338002825
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: Health Professional
• Device Catalogue Number: 322001
• Device Lot Number: LA181918BV-P1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Distributor Facility Aware Date: 06/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1