MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY HARD WIRE BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G22002
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the video provided with this report because the product said to be involved was not provided to cook for evaluation.The lot number provided in the video matches this report.The label in the video matches the product reported.Our evaluation of the video provided confirmed the report.The handle and distal end of the device are visible, along with the device labeling.In the video it can be seen that the user is manipulating the handle; however, the distal end of the device is unresponsive as the basket remains partially advanced throughout the manipulation.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our evaluation of the video provided confirmed the report.However, a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.Prior to distribution, all memory hard wire baskets are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.This observation occurred prior to use.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an unknown procedure the physician used a cook memory hard wire basket.A video was provided showing the user experiencing difficulty and inability to retract the basket.This occurred prior to patient contact; there was no impact to the patient.In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.
Event or Problem Description
This supplemental emdr is being sent to cancel the initial emdr.See h11 for further justification.
Additional Manufacturer Narrative
This mdr follow up report is being submitted to cancel the initial report submitted relating to this event.The evaluation determined that the baskets that were returned, are able to be retracted and partially advanced without resistance during tabletop testing to mimic prior to use testing conditions.Upon this observation and further review of the video it is likely that the lack of retraction noted in the video may be attributed to the handle being manipulated in the coiled position which can hinder retraction rather than a true inability to retract.The complaint is now believed to be directed to the inability of the baskets to fully advanced, which has not historically caused or contributed to a serious injury or death.Based on further quality and medical evaluation this incident no longer meets the reporting criteria of an fda mdr report.

• Brand Name: MEMORY HARD WIRE BASKET
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 21752897
• Report Number: 1037905-2025-00258
• Device Sequence Number: 8263847
• Product Code: FFL
• UDI-Device Identifier: 00827002220027
• UDI-Public: (01)00827002220027(17)271023(10)W4881825
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: G22002
• Device Catalogue Number: MWB-2X4
• Device Lot Number: W4881825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown