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

Catalog Number WEB-3X6

Device Problems Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 06/19/2022

Event Type  Injury  

Event Description

During a procedure to remove a cbd stone from the duodenum, the physician used the web extraction basket.It was reported that when tried to remove the stone by moving the basket handle, the tip of the basket hit the duodenum, causing perforation in the patient.The procedure was finished after hemostasis with a clip on the perforated area.A section of the device did not remain inside the patient¿s body.

Manufacturer Narrative

The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The photos provided show the device inside the package and the outer package with a label that matches the report.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with the basket fully retracted and coiled.The basket was advanced and retracted with no issues.During a visual examination the basket was not damaged/broken and the distal tip was smooth.There were no anomalies noted with the returned device.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 laboratory evaluation of the returned device could not confirm the report.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause, however, a device failure was not observed.Prior to distribution, all the web 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.The likelihood of occurrence is considered rare.This is an isolated occurrence.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: THE WEB 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: 15020529
• MDR Text Key: 295953132
• Report Number: 1037905-2022-00391
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002227788
• UDI-Public: (01)10827002227788(17)230715(10)W4365192
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Catalogue Number: WEB-3X6
• Device Lot Number: W4365192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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 TJF 260V
• Patient Outcome(s): Required Intervention