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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that the physician was performing an unspecified procedure on a patient by using cook® single-use holmium laser fiber.During the procedure, the fiber broke inside of the scope under low power.The physician pulled out the broken fiber and completed the procedure with a second laser fiber.No unintended section of the device remained inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information has been provided at this time.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, instructions for use (ifu), quality controls, manufacturing instructions and visual inspection was conducted on the returned device during the investigation.One device was returned to the manufacturer for evaluation.No obvious manufacturing anomalies were observed on the returned device.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record did not observe any non-conformances that may have contributed to this incident.A review of instructions for use (ifu) was performed which captures the failure mode of this complaint.Additionally, a review of complaint history found no other complaints associated with the failure mode of this complaint device's lot number.Based on the provided information a definitive root cause can not be determined at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK® 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: 6577874
• Report Number: 1820334-2017-01051
• Device Sequence Number: 16366952
• Product Code: GEX
• UDI-Device Identifier: 00827002237339
• UDI-Public: (01)00827002237339(17)190824(10)7222787
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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-S200-H30
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1