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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
While performing a ureteral calculi procedure on a patient, the fiber broke inside the kidney.The physician plans to have the patient return for removal of additional stones.The fiber's locations is unknown at this time.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation.The device is shipped with an instruction for use that describes the intended use, specific items are addressed such as: " 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 the hospital site.Discard any fiberoptic assembly that is cracked, broken or does not meet minimum transmission standards." the complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.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 information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.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 and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
While performing a ureteral calculi procedure on a (b)(6) female patient, the fiber broke inside the kidney.The physician plans to have the patient return for removal of additional stones.The fibers location is unknown at this time.No additional information has been provided regarding patient outcome.

• 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: 5756575
• Report Number: 1820334-2016-00575
• Device Sequence Number: 10769131
• Product Code: GEX
• UDI-Device Identifier: 00827002485266
• UDI-Public: (01)00827002485266(17)190318(10)6823735
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2016

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 Model Number: N/A
• Device Catalogue Number: HLF-S273-SMA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 09/26/2016
• 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: Other
• Patient Age: 58 YR