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

Catalog Number	HLF-S200-HSMA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D10.Concomitant medical products and therapy dates: therapy date: (b)(6) 2024, hl-30c - cook medical rhapsody h-30 holmium laser system.E3: occupation: pharmacist manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.
Event or Problem Description
As reported, during a ureteroscopy, a crack in the cook® single-use holmium laser fiber was observed.The energy from the fiber was observed on the instrument table.Another laser fiber was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects to the patient or staff.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation as reported, during a ureteroscopy, a crack in the cook® single-use holmium laser fiber was observed.The energy from the fiber was observed on the instrument table.Another laser fiber was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects to the patient or staff.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control procedures.Additionally, a visual inspection of the device and a personnel interview were conducted.A device failure analysis was conducted as the cook® single-use holmium laser fiber was returned by the customer.The fiber was noted to have a dark spot on the white sheath and the laser was found to be broken at this spot.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Given the inspection procedures prior to shipment and the lack of lot nonconformances and other complaints, there is no reason to suspect that the device was not made to specification.Cook also reviewed product labeling.The product ifu, [t_hsmas_rev2] ¿hsma holmium laser fiber (single-use)¿ contains the following information related to the reported failure mode.¿warnings ¿do not bend fiber at sharp angles.¿ ¿precautions ¿never subject fiberoptics to sharp bends in handling, use, or storage¿ ¿how supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, the cause of the failure mode was unable to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 ; 8123392235
• MDR Report Key: 18564220
• Report Number: 1820334-2024-00108
• Device Sequence Number: 15101939
• Product Code: GEX
• UDI-Device Identifier: 00827002252936
• UDI-Public: (01)00827002252936(17)241220(10)14430957
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2024

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: 12/20/2024
• Device Catalogue Number: HLF-S200-HSMA
• Device Lot Number: 14430957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/25/2024; Not provided
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/16/2024; 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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 Age: 32 YR
• Patient Sex: Unknown