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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The ifu states that a number of different factors affect the life of any particular fiber, including: ¿lasing with a contaminated or damaged proximal end.¿ physical examination/visual inspection: device was returned for evaluation in two sections.It was observed that the fiber was separated 90.5 cm from the distal tip; this section of fiber was broken in a second location at 80 cm, cladding was partially separated keeping the section attached by cladding; under magnification scrapes were visualized on the blue cladding near this point of separation.The proximal segment measured approximately 202 cm long; total length of fiber returned was approximately 292.5 cm.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.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.
Event or Problem Description
It was reported that the physician removed the broken piece of cook single-use holmium laser fiber from the patient using a basket.Cook rhapsody h-30 laser machine was use to perform the procedure.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence but it extended operating room and anesthesia time for the patient by few minutes.There were no adverse effects to the patient.

• 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: 6460094
• Report Number: 1820334-2017-00528
• Device Sequence Number: 563990
• Product Code: GEX
• UDI-Device Identifier: 00827002237339
• UDI-Public: (01)00827002237339(17)191116(10)7448741
• 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
• Report Date (Section B): 04/04/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HLF-S200-H30
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/05/2017
• 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