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

Model Number	G25297
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a cook® single-use holmium laser fiber was kinked / bent in the packaging then "snapped" completely while handling it.The fiber was not used.Another fiber was used to complete the procedure.No unintended section of the device remained inside the patient's body.The complainant has not reported any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Event summary: as reported, a cook® single-use holmium laser fiber was kinked / bent in the packaging then "snapped" completely while handling it.The fiber was not used.Another fiber was used to complete the procedure.No unintended section of the device remained inside the patient's body.The complainant has not reported any adverse effects on the patient due to this occurrence.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as visual inspection of the device were conducted.The device was returned to cook in a shipping tray with an opened pouch for investigation.The laser fiber was returned in two segments.The point of separation is the shaft of the fiber.The distal segment measures approximately 113 cm.The proximal segment measures approximately 186 cm.A document-based investigation evaluation was performed.No related non-conformances were recorded.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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state on how to supply, "supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred." additionally, the ifu warns."do not bend fiber at sharp angles.Fiber should be clamped with forceps or other securing instruments as it could result in fiber damage or breakage." based on the available information, cook has concluded a cause for the complaint cannot be established.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.

• 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: 16707737
• Report Number: 1820334-2023-00388
• Device Sequence Number: 3640955
• Product Code: GEX
• UDI-Device Identifier: 00827002252974
• UDI-Public: (01)00827002252974(17)240406(10)13875306
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 04/06/2024
• Device Model Number: G25297
• Device Catalogue Number: HLF-S940-HSMA
• Device Lot Number: 13875306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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 Sex: Unknown