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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at time of event is currently unknown as requested but not provided.Patient sex at time of event is currently unknown as requested but not provided.It is currently unknown if this device was reprocessed and reused on a patient as this information was not provided.(b)(4).This event is currently under investigation.
Event or Problem Description
During a ureteroscopy lazer lithotripsy procedure, the tip of the optilite multi-use holmium laser fiber came off in the patient.The physician was able to retrieve the tip with no harm to the patient.The tip of the device was successfully removed.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Patient age at time of event is currently unknown as requested but not provided.Patient sex at time of event is currently unknown as requested but not provided.It is currently unknown if this device was reprocessed and reused on a patient as this information was not provided.(b)(4).Event evaluation: a review of complaint history, device history record, instructions for use (ifu), specifications and trends was conducted during the investigation.No product or images were returned to assist with this investigation.Specific to this case the product ifu details: " note: basic tips on handling fiberoptic devices: never subject fiberoptics to sharp bends in handling, use, storage or reprocessing; it is recommended that only facilities that are adequately designed, equipped, monitored and staffed by trained personnel should undertake surgical fiber reprocessing at hospital site; discard any fiberoptic assembly that is cracked, broken or does not meet minimum transmission standards." there is no evidence to suggest this device was not manufactured to current specifications.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.The appropriate internal personnel have been notified of this event and we will continue to monitor for similar incidents.
Event or Problem Description
During a ureteroscopy lazer lithotripsy procedure, the tip of the optilite multi-use holmium laser fiber came off in the patient.The physician was able to retrieve the tip with no harm to the patient.The tip of the device was successfully removed.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: OPTILITE MULTI-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: 5508440
• Report Number: 1820334-2016-00175
• Device Sequence Number: 10820383
• Product Code: GEX
• UDI-Device Identifier: 10827002485225
• UDI-Public: (01)10827002485225(17)181027(10)6325250
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K073496
• 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): 02/26/2016

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 Model Number: N/A
• Device Catalogue Number: HLF-M273-SMA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2016
• Device Age: 4 MO
• Event Location: Ambulatory Surgical Facility
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2016
• Supplement Report FDA Received Date: 04/07/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other