MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION LITHOTRIPSY EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number FS-LXB-2X4

Device Problems Nonstandard Device (1420); Material Split, Cut or Torn (4008)

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

Event Date 06/02/2023

Event Type  malfunction  

Event Description

During lithotripsy in the bile ducts, the physician used a cook fusion lithotripsy extraction basket.It was reported that a stone was captured during the procedure; however, during an attempt to remove the stone, it turned out that it was too large and would not pass through vater's papilla, so a lithotripsy procedure was performed.During the tensioning of the basket in order to break the deposit into smaller elements, the cable in the lithotripter handle was damaged, which prevented further lithotripsy.The staff prepared tools for emergency lithotripsy [use of a lithotriptor handle] to remove the basket from the bile ducts, and then the patient was placed under a prosthesis and left for observation.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

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: a corrective action has been initiated to reduce occurrences of drive wire breakage/detachment.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion lithotripsy extraction 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was included in the scope of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report.The device returned with the handle in the "retracted" position with the basket assembly removed from the sheath.The basket has been bent/ deformed.A bend was noted in the drive wire 117.8 cm distal to the proximal end of the basket assembly.Significant damage was not noted at the proximal end of the basket assembly wires under magnification.The cover plate and t-nut were removed from the handle to evaluate if the cannula had been torqued properly.The set screws and t-nut were noted to already be loose prior to removal.Upon visual inspection the deformation on the cannula was not sufficient, while there are indentations from the screws, the cannula has not been compressed to adequately secure the basket assembly.This indicates insufficient force applied during the torquing process.This is a likely cause for the drive wire detachment and the device is therefore, considered nonconforming.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 returned device confirmed cannula and drive wire was insufficiently torqued during the manufacturing process, leading to drive wire detachment.A field action has been initiated for this nonconformance (062-r); the reported lot, w4647284, is within the scope of this action.A notification of operator related complaint form was provided to production management to make them aware of an operator related complaint and an operator retraining has been completed.A corrective action has been initiated to reduce occurrences of drive wire breakage/detachment.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion lithotripsy extraction 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: FUSION LITHOTRIPSY EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• 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: 17297050
• MDR Text Key: 319120117
• Report Number: 1037905-2023-00332
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482774
• UDI-Public: (01)10827002482774(17)251018(10)W4647284
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-2X4
• Device Lot Number: W4647284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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
• Treatment: BOSTON JAGTOME SPHINCTEROTOME; OLYMPUS ENDOSCOPE: TJF-160VR; OLYMPUS STENTS AND STENT INSERTION KIT