MAUDE Adverse Event Report: COOK ENDOSCOPY THE WEB EXTRACTION BASKET; FFL

Catalog Number WEB-2X4

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Lithotripter handle, unknown make or model.Initial reporter; occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved determined that the drive wire was broken.A section of the distal end of the basket was included in the return; there was no handle or sheath included with the return.The drive wire was broken and frayed at the proximal end of the returned portion of the device.The drive wire was bent from the distal end.The basket was misshapen and a white substance was observed under the tip.The handle of the device was not included in the return.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 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.Due to the condition of the returned device (length of returned basket wire, lack of sheath, bends in the wire at the proximal end), we have concluded that the incident occurred during mechanical lithotripsy.The instruction for use (ifu) for the soehendra lithotripsy handle [compatible lithotripter handle] states in regards to mechanical lithotripsy, "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 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.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 user used a cook web extraction basket.The user planned to capture a large stone and tangle the wire onto handle [lithotripter handle].The user found out the device was broken during the stone removal at hand hold area.This event was not reportable at the time.The device was received on 26-nov-2019 and it was noted the wire was broken at the proximal end.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
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station road; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station road; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station road; winston-salem, NC 27105
• MDR Report Key: 9516126
• MDR Text Key: 220059027
• Report Number: 1037905-2019-00789
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Catalogue Number: WEB-2X4
• Device Lot Number: W4214884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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