MAUDE Adverse Event Report: COOK ENDOSCOPY THE WEB EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number WEB-2X4

Device Problems Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: our photo and laboratory evaluation of the product said to be involved confirmed the report and determined the handle disconnected from the drive wire.The device was returned with the basket fully extended from the tubing.The handle was loose and there was no movement from the basket when the handle was manipulated.The sheath had a bend from approximately 5.2 cm to 16.0 cm distal to the handle.The black hub collet on the proximal end of the handle was unscrewed, and it was noted that the handle disconnected from the drive wire.The pin vise collet was disconnected from the cable basket wire.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: the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use (ifu) states " pulling on the sheath while advancing or retracting basket may damage device, rendering it inoperable." prior to distribution, all the web 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 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.

Event Description

During an endoscopic procedure, the physician used a web extraction basket.The user checked the device before the procedure and found out that the basket could not be closed properly.The user then changed to another device that was the same to complete the procedure.This event occurred prior to patient or endoscopic contact.On (b)(6) 2020, the device was evaluated and it was determined that handle disconnected from the drive wire [subject of report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This correction follow up report is being submitted to update the investigation evaluation and corrective action.Investigation evaluation: our photo and laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully extended from the tubing.The handle was loose and there was no movement from the basket when the handle was manipulated.The sheath had a bend from approximately 5.2 cm to 16.0 cm distal to the handle.The black hub collet on the proximal end of the handle was unscrewed, and it was noted that the handle disconnected from the drive wire.Pin vise collet was disconnected from the cable basket wire.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: the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use (ifu) states " pulling on the sheath while advancing or retracting basket may damage device, rendering it inoperable." prior to distribution, all the web 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 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

During an endoscopic procedure, the physician used a web extraction basket.The user checked the device before the procedure and found out that the basket could not be closed properly.The user then changed to another device that was the same to complete the procedure.This event occurred prior to patient or endoscopic contact.On 15-jul-2020, the device was evaluated and it was determined that handle disconnected from the drive wire [subject of report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: THE WEB EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10368954
• MDR Text Key: 201771745
• Report Number: 1037905-2020-00307
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002227764
• UDI-Public: (01)10827002227764(17)221105(10)W4282157
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Catalogue Number: WEB-2X4
• Device Lot Number: W4282157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR