MAUDE Adverse Event Report: COOK INC COOK® SINGLE-USE HOLMIUM LASER FIBER

Catalog Number	HLF-S365-HSMA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: gex, powered laser surgical instrument.(b)(4).The 510(k): k124030.The event is currently under investigation.
Event or Problem Description
During a ureteroscopy procedure, the fiber broke off inside the patient.Laser settings were 12hz and 1000mj.The separated portion was retrieved using a stone retrieval basket.No adverse affects to the patient have been reported.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, instructions for use (ifu), manufacturing instructions, specifications, and quality control of the device was conducted during the investigation.The device ifu details precautions that may affect the life of the fiber as well as guidance on how to prevent damage of the fiber from occurring.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the available level of information a definitive root cause could not be determined, however it is possible that this device became damaged during use, re-sterilization at the user facility, or during handling of the device.We will continue to monitor for similar incidents.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a ureteroscopy procedure, the fiber broke off inside the patient.Laser settings were 12hz and 1000mj.The separated portion was retrieved using a stone retrieval basket.No adverse affects to the patient have been reported.

• Brand Name: COOK® SINGLE-USE HOLMIUM LASER FIBER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5531272
• Report Number: 1820334-2016-00208
• Device Sequence Number: 963837
• Product Code: GEX
• UDI-Device Identifier: 00827002252950
• UDI-Public: (01)00827002252950(17)170501(10)4958906
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: HLF-S365-HSMA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2016
• Device Age: 22 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention