MAUDE Adverse Event Report: COOK INC OPTILITE SINGLE-USE HOLMIUM LASER FIBER; GEX LASER INSTRUMENT, SURGICAL

Catalog Number	HLF-S273-CNV
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the optilite single-use holmium laser fiber snapped while lasering.It is unknown if the procedure was completed, but there were no injuries or additional procedures reported.

• Brand Name: OPTILITE SINGLE-USE HOLMIUM LASER FIBER
• Common Device Name: GEX LASER INSTRUMENT, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7744226
• Report Number: 1820334-2018-02394
• Device Sequence Number: 1678231
• Product Code: GEX
• UDI-Device Identifier: 00827002486140
• UDI-Public: (01)00827002486140(17)190111(10)6512026
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2018

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: Health Professional
• Device Expiration Date: 01/11/2019
• Device Catalogue Number: HLF-S273-CNV
• Device Lot Number: 6512026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1