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

Catalog Number FS-LXB-2X4

Device Problem Unintended Collision (1429)

Patient Problems No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Date 03/19/2014

Event Type  Injury  

Event Description

During the procedure, a cook fusion lithotripsy extraction basket was used for stone extraction in the common hepatic duct.During extraction of a 1.5 mm stone, the basket embedded into the stone [stone impaction].Further manipulation would not open or close past half way point.The handle was cut off and patient was sent to operating room for surgery to remove the basket and stone successfully.The handle was cut off and the patient was sent to the operating room for surgery to remove the basket and stone.Surgery was successful and 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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: 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.The instructions for use state: "visually inspect with particular attention to kinks, bends and breaks, if an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use caution the user: "caution: if difficulty is encountered when removing basket from duct, do not use excessive force.Moderate force may be applied by closing handle to manually fracture stone." the instructions for use for the fusion lithotripsy extraction basket includes the following warning: "basket wires may fragment and/or stone impaction may occur during lithotripsy, requiring surgical intervention." prior to distribution, all fusion lithotripsy extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an unusual 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.

• Brand Name: FUSION LITHOTRIPSY EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd. &; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3779247
• MDR Text Key: 4432239
• Report Number: 1037905-2014-00136
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-2X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OLYMPUS ENDOSCOPE (UNK MODEL NUMBER); ALLIANCE GUN
• Patient Outcome(s): Required Intervention