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

Catalog Number WEB-3X6

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: medwork lithotripter handle, unknown model.Cook soehendra lithotriptor cable, slc-2.Cook soehendra lithotriptor handle, slh-1.Cook conquest ttc lithotriptor cable, ttcl-10.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 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.The web basket instructions for use (ifu) states, "endoscopically or fluoroscopically visualize extraction target and advance basket to appropriate position.Place sheath of basket beyond target before extending basket to entrap extraction target.After confirming desired position of basket sheath relative to target, advance basket out of sheath.Place basket around extraction target and slowly retract handle until entrapment is achieved.Note: it may be necessary to move basket back and forth along target in order to capture object." the report indicates that the cook conquest ttc lithotriptor cable (ttcl-10) was used with a medwork lithotripsy handle.The ifu for the ttcl-10 states that the ttcl-10 is "used in conjunction with a side-viewing endoscope, cook endoscopy lithotripsy-compatible baskets, and a soehendra lithotriptor handle." the ttcl-10 is not intended for use with a medwork lithotripsy handle.The report indicates that the outer sheath was removed from the basket prior to lithotripsy.While this is correct for the ttcl-10, the ifu for the soehendra lithotripsy cable (slc-2) state, "do not remove sheath from basket wire." the ifu of the soehendra lithotriptor handle (slh-1) warns, "due to the varying compositions of biliary stones, stone fracture may not be possible.If the stone cannot be fractured, continued rotation of the handle may cause the basket wire to break, requiring surgical intervention." prior to distribution, all web extraction baskets are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.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 a stone removal procedure, the physician used a cook the web extraction basket.The cables in the upper area of the basket were torn after being threaded into the lithotriptor handle [drive wire breaks].In addition, the stone in relation to the basket became loose [stone came out of the basket].The procedure was completed with another manufacturer's extraction baskets.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
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8927976
• MDR Text Key: 200435926
• Report Number: 1037905-2019-00493
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WEB-3X6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• 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