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

Model Number	G25293
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event summary: it was initially reported that a cook® single-use holmium laser fiber was unable to be detected by the laser unit.Physician used another laser fiber to complete the procedure.Upon device return and investigation on 30-nov-2021, it was noted that the laser fiber was disconnected at the hub, and there was charring noted on the proximal end of the device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), documentation, the instructions for use, manufacturing instructions, specifications, and quality control data.The device failure analysis noted: the device was returned in an opened package, and the laser fiber was severed at the base of the red silicone cover/hub.The points of separation are charred.Functional testing could not be performed, and therefore unable to recreate the failure mode.A review of the device history record found no non-conformance's related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of relevant manufacturing documents was conducted.It was concluded that the device was functionally inspected by quality control and no notable gaps in production or processing controls were noted.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: open any laser aperture cover or door and insert the proximal connector into the laser system; screw in finger-tight.Based on the investigation the device was returned severed.The points of the separation were charred.Functional testing could not be performed and therefore unable to recreate reported failure mode.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It was initially reported that a cook® single-use holmium laser fiber was unable to be detected by the laser unit during a ureteroscopy procedure.Physician used another laser fiber to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence upon device return and investigation on 30-nov-2021, it was noted that the laser fiber was disconnected at the hub, and there was charring noted on the proximal end of the device.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 13006901
• Report Number: 1820334-2021-02678
• Device Sequence Number: 5441728
• Product Code: GEX
• UDI-Device Identifier: 00827002252936
• UDI-Public: (01)00827002252936(17)231030(10)13524963
• Combination Product (Y/N): N
• PMA/510(K) Number: K133788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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 Expiration Date: 10/30/2023
• Device Model Number: G25293
• Device Catalogue Number: HLF-S200-HSMA
• Device Lot Number: 13524963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown