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

Model Number N/A

Device Problem Break (1069)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported, during pyeloscopy and laser lithotripsy procedure, the cook® single-use holmium laser fiber was opened and screwed into the laser aperture.The fiber was detected without issue.Fiber was switched to ready and the laser was used without any initial issues.The scrub nurse was pumping irrigation fluid with her right hand and holding the fiber with her left hand.Just as the case was finishing the nurse pumped the irrigation fluid and then felt a sharp pain on her left palm.The fiber had snapped and caused a small burn on the scrub nurses' left palm.The laser was immediately stopped, and the fiber was removed from the scope.There was no injury to the patient, but the scrub nurse was treated for her burn by her fellow staff members.The scrub nurse indicated that she may have inadvertently squeezed the fiber instead of the irrigation tubing, but she couldn't be sure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer postal code = (b)(6).E3: customer occupation = inventory 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 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.

Manufacturer Narrative

Event description: it was reported, during pyeloscopy and laser lithotripsy procedure, the cook® single-use holmium laser fiber was opened and screwed into the laser aperture.The fiber was detected without issue.Fiber was switched to ready and the laser was used without any initial issues.The scrub nurse was pumping irrigation fluid with her right hand and holding the fiber with her left hand.Just as the case was finishing the nurse pumped the irrigation fluid and then felt a sharp pain on her left palm.The fiber had snapped and caused a small burn on the scrub nurses' left palm.The laser was immediately stopped, and the fiber was removed from the scope.There was no injury to the patient, but the scrub nurse was treated for her burn by her fellow staff members.The scrub nurse indicated that she may have inadvertently squeezed the fiber instead of the irrigation tubing, but she couldn't be sure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.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 (ifu), and quality control procedures.One cook® single-use holmium laser fiber was returned without package or label.The fiber was returned in 2 pieces with obvious burn marks on the laser fiber at the point of separation.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 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.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.If visible light (aiming beam) can be seen leaking from the fiber, fiber failure may result when therapeutic energy is applied as the fiber is deflected beyond the optical limits of total internal reflection.Fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.Precautions 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 laser beam alignment or focus, never subject fiberoptics 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.Do not exceed recommended power limits.How supplied upon removal from package, inspect the product to ensure no damage has occurred.The customer reported that the laser was used without any initial issues.Based on the available information, it is most likely the laser fiber was damaged during procedural handling of the device.The product ifu states, "never subject fiberoptics to sharp bends in handling, use, or storage." 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.

Event 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
• Type of Device: 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: 18773063
• MDR Text Key: 337072846
• Report Number: 1820334-2024-00262
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K163197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HLF-S273-H30
• Device Lot Number: 15621945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1