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

Model Number	G25294
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility medwatch report # mw5110034 was received and the report showed that the customer reported: during a ureteroscopy with laser lithotripsy for left urolithiasis, a 2 mm piece of a cook® single-use holmium laser fiber broke during procedure and could not be retrieved from the patient's kidney.Attempts to find the piece were abandoned, as the risks of continuing to search for it did not outweigh the benefits.There is low risk to the patient especially since the piece of fiber may wash out on its own.A clinical disclosure was done with the patient and his family, and this was documented in the operative report.The patient will have follow-up which includes a computed tomography (ct) scan at about 4 weeks post removal of the ureteral stent that was placed during the procedure.No additional patient consequences were reported.Additional information has been requested.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Summary of event the user facility filed a medwatch report [mw5110034] on (b)(6) 2022.This report was received by cook on 27jun2022.The report stated that a single-use holmium laser fiber [g25294-hlf-s273-hsma; 14120540] was used for a ureteroscopy with laser lithotripsy for left urolithiasis on (b)(6) 2022.No additional information was provided regarding patient pre-existing conditions, anatomy, etc.It was reported that during the procedure a 2mm segment of the device broke and could not be retrieved from the patient¿s kidney.Attempts to find the piece during the procedure were abandoned, as the user felt the risks of continuing to search for it did not outweigh the benefits.A clinical disclosure was done with the patient and his family, and this was documented in the operative report.The patient will have follow-up which includes a computed tomography (ct) scan at about 4 weeks post removal of the ureteral stent that was placed during the procedure.Investigation evaluation reviews of the complaint history, device history record, instructions for use, manufacturer¿s instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Due diligence was completed to the retrieve the complaint device, however the product has yet to be received.If the product is received at a later time, the complaint file will be updated accordingly.Accordingly, no physical examination could be performed.A document-based investigation evaluation was performed.A review of the device history record found no related nonconformances.A complaint history database search revealed no other complaints associated with lot number 14120540.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The device is provided with instructions for use which caution, "a number of different factors affect the life of any particular fiber, including: continuous lasing with the fiber tip in contact with tissue.Never subject fiberoptics to sharp bends in handling, use, or storage." based upon the available information and results of the investigation, cook has concluded that the cause for the complaint was due to an unintended user error that caused or contributed to event.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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.
Event or Problem Description
Correction of date of event from 25jun2022 to 25may2022 as per medwatch report.

• 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: 15086315
• Report Number: 1820334-2022-01261
• Device Sequence Number: 17433561
• Product Code: GEX
• UDI-Device Identifier: 00827002252943
• UDI-Public: (01)00827002252943(17)240730(10)14120540
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 07/30/2024
• Device Model Number: G25294
• Device Catalogue Number: HLF-S273-HSMA
• Device Lot Number: 14120540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown