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

Model Number	G23734
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Name and address - phone: (b)(4).Occupation - administration officer.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 laser lithotripsy, the tip of a cook single-use holmium laser fiber broke/separated when inserted into an unspecified laser resectoscope.The user was unable to pass the fiber through the resectoscope, as the "button" was getting stuck.After the fiber tip broke off, bladder irrigation was passed through the distal end of the resectoscope, and the broken tip was not found.The user checked the bladder for the separated portion of the device, which was unable to be located.Additional patient/event information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a laser lithotripsy, the tip of a cook single-use holmium laser fiber broke/separated when inserted into an unspecified laser resectoscope.The user was unable to pass the fiber through the resectoscope, as the "button" was getting stuck.After the fiber tip broke off, bladder irrigation was passed through the distal end of the resectoscope, and the broken tip was not found.The user checked the bladder for the separated portion of the device, which was unable to be located.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned for investigation in open packaging.The laser fiber measured 290cm.The clear tip was missing, and approximately 3mm of blue tubing was smashed at the distal end.A document-based investigation evaluation was performed.No related non-conformances were recorded.Review of the work order revealed all devices had passing detection results.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿a number of different factors affect the life of any particular fiber, including: ¿ extended lasing at high power ¿ continuous lasing with the fiber tip in contact with tissue ¿ lasing with a contaminated or damaged proximal end ¿ improper handling ¿ poor beam alignment or focus ¿ never subject fiber optics to sharp bends in handling, use, or storage.¿ always keep connector-end dry and free from contaminants.¿ discard any fiberoptic assembly that is cracked or broken, or does not meet minimum transmission standards.¿ ferrule dust cap should stay attached when the fiber not connected to the laser system.¿ do not use this laser fiber in the presence of flammable anesthetics or combustible materials.¿ do not exceed recommended power limits.¿ based on the available information and a clinical assessment of the event, cook has concluded that it is most likely the user subjected the laser to sharp angles during the procedure, causing the breakage.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 14690405
• Report Number: 1820334-2022-01056
• Device Sequence Number: 17474519
• Product Code: GEX
• UDI-Device Identifier: 00827002237346
• UDI-Public: (01)00827002237346(17)240409(10)13883942
• Combination Product (Y/N): N
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2024
• Device Model Number: G23734
• Device Catalogue Number: HLF-S550-H30
• Device Lot Number: 13883942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK RHAPSODY H30 LASER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown