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	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during ureteroscopic laser fragmentation of calculus, the end of a cook® single-use holmium laser fiber broke in the ureter.The procedure was completed with a new laser fiber.No section of the device remained 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.Additional information has been requested.At the time of this report, no further information has been provided.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Event summary: as reported, during ureteroscopic laser fragmentation of calculus, the end of a cook® single-use holmium laser fiber broke in the ureter.The procedure was completed with a new laser fiber.No section of the device remained 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.Additional information has been requested.At the time of this report, no further information has been provided.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), the instructions for use, manufacturing instructions, and quality control data.One cook single-use holmium laser fiber was returned in a shipping tray inside a open outer package.The distal end of blue cladding was observed to be charred.The clear fiber does not protrude the blue cladding, but the clear fiber was visible inside the blue cladding.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: a number of different factors affect the life of any particular fiber, including.Improper handling.Poor laser beam alignment or focus.Continuous lasing with the fiber tip in contact with tissue.Never subject fiber optics to sharp bends in handling, use, or storage.Extended lasing at high power, discard any fiberoptic assembly that is cracked or broken or does not meet minimum transmission standards.The returned laser fiber was returned with no clear fiber protruding from the distal tip of the blue cladding and the blue cladding was observed to be charred.A review of the device history record found no related anomalies and no other complaints have been reported for the same lot.A review of production processes and quality inspection documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the ifu identified a list of factors is provided that affect the life of any particular fiber.Cook has concluded a cause of the complaint cannot be established.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 12750650
• Report Number: 1820334-2021-02437
• Device Sequence Number: 12260252
• Product Code: GEX
• UDI-Device Identifier: 00827002252936
• UDI-Public: (01)00827002252936(17)231231(10)13660916
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/28/2022

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: 12/31/2023
• Device Model Number: G25293
• Device Catalogue Number: HLF-S200-HSMA
• Device Lot Number: 13660916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RHAPSODY H-30 HOLMIUM LASER SYSTEM; RHAPSODY H-30 HOLMIUM LASER SYSTEM
• Patient Sex: Unknown