MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY HARD WIRE EXTRACTION BASKET; LQR DISLODGER, STONE, BILIARY

Catalog Number MWB5-1.5X3.5

Device Problems Product Quality Problem (1506); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

In preparation for a procedure, the user selected a cook memory hard wire extraction basket.It was reported that the user detected the sheath broken upon opening the package.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

Manufacturer Narrative

Investigation evaluation: 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.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all memory hard wire extraction basket 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: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional information section for this justification.

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 handle was bent, not broken; 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 EXTRACTION BASKET
• Type of Device: LQR DISLODGER, STONE, BILIARY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 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: 14487948
• MDR Text Key: 292500109
• Report Number: 1037905-2022-00244
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002218618
• UDI-Public: (01)10827002218618(17)240512(10)W4470199
• Combination Product (y/n): N
• PMA/PMN Number: K171969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWB5-1.5X3.5
• Device Lot Number: W4470199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 63 KG