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

Model Number	G23553
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the scrub nurse noticed during an unspecified procedure, the tip of the cook® single-use holmium laser fiber was bent, where it should have remained straight.The device was not caught on anything prior to use.Blue fragments were found to have come from the fiber and floating within the bladder area.The surgeon catheterized the patient post procedure to flush any fragments that may have remained within the patient.No patient harm has been reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
E1: name and address: phone: (b)(6).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
Additional information was received 20sep2024: the procedure being performed was a ureteroscopy.The fiber was inspected for damage prior to use.The surgeon continued using the laser fiber after the tip broke off, and was able to complete the procedure using the fiber.There was no manipulation of the fiber that occurred that may have damaged the fiber.There were no adverse effects to patient and the procedure was completed without injury.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Additional information: b5, d10, event description: it was reported that the scrub nurse noticed, during a ureteroscopy, the tip of a cook® single-use holmium laser fiber was bent where it should have remained straight.The fiber was inspected for damage prior to use.The device was not caught on anything prior to use.The surgeon continued using the laser fiber after the tip broke off, and was able to complete the procedure using the fiber.There was no manipulation of the fiber that occurred that may have damaged the fiber.Blue fragments were found to have come from the fiber and were floating within the bladder area.The surgeon catheterized the patient post procedure to flush any fragments that may have remained within the patient and was not concerned that this would be an issue.The patient did not require any additional procedures due to this occurrence.There were no adverse effects to the patient and the procedure was completed without injury.Investigation - evaluation : reviews of complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and interview of personnel were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.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 device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user 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, no returned device, and the results of the investigation, the cause of the failure was unable to be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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 ; 8123392235
• MDR Report Key: 20127529
• Report Number: 1820334-2024-01156
• Device Sequence Number: 7417833
• Product Code: GEX
• UDI-Device Identifier: 00827002235533
• UDI-Public: (01)00827002235533(17)261207(10)15794173
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163197
• 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): 10/02/2024

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 Model Number: G23553
• Device Catalogue Number: HLF-S273-H30
• Device Lot Number: 15794173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• 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: COOK MEDICAL RHAPSODY H-30 HOLMIUM LASER SYSTEM
• Patient Sex: Unknown