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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY THE WEB EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number WEB-3X6
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 04/29/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: non-healthcare professional. Concomitant medical products: cook soehendra lithotriptor handle, slh-1. Cook soehendra lithotripsy cable, slc-2. Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation. Per the photos provided we cannot complete a full evaluation. Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event. The lot number provided in the photos matches this report. The label in the photo matches the product reported. One of the pictures provided shows the device after use and surgical removal in addition to the device packaging. The photo shows all portions of the device except the catheter/sheath, the basket connected to the drive wire cable, a portion of the drive wire cable that appears to be the portion that was attached to the lithotripsy handle and the basket handle. The basket wires are deformed but still attached at the base and attached to the drive wire cable. The photo shows the handle and a small portion of drive wire cable where it was cut for lithotripsy. There is a break in the drive wire cable; we were unable to determine the location of the break. The catheter is not present on any portion of the drive wire cable. A scan of the device label is also provided. The other image provided shows a fluoroscopic image of the device in the patient. The drive wire cable appears mangled and disconnected from the device handle. 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. Evaluation 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 instructions for use for this device includes the following: "surgical intervention may be required if impaction occurs. " the instructions for use of the sohendra lithotriptor handle 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 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 emergent endoscopic retrograde cholangiopancreatography (ercp) with planned lithotripsy for acute cholangitis due to the stent having moved proximally to the stone and removal of a large gallstone in the common hepatic duct, the physician used a web extraction basket to extract the large gallstone. The basket wire broke and it was not possible to retrieve the basket, which remained stuck in the bile duct around the stone. A 12 cm plastic stent was placed proximally to the gallstone to drain the biliary ducts. The patient required surgery including adhesiolysis (removal of adhesions), choledochotomy (incision into the common bile duct) via coelioscopy, extraction of the basket, stent, and trapped gallstone as well as other stones in the common bile duct (cbd), luchka suturing of the duct, and placement of a kehr drain. The patient had a perioperative cholangiography and cholangioscopy as well. The medical device was recovered and set aside for possible expert analysis. The patient is reported to be doing well. A section of the device, the basket, remained inside the patient¿s body following the procedure, so the patient required surgery to remove the device. According to the reporter, the patient recovered following the surgery.
 
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Brand NameTHE WEB EXTRACTION BASKET
Type of DeviceFFL, 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 Key10113934
MDR Text Key193622334
Report Number1037905-2020-00232
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/03/2021
Device Catalogue NumberWEB-3X6
Device Lot NumberW4153089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/03/2020 Patient Sequence Number: 1
Treatment
PENTAX DUODENOSCOPE, UNKNOWN MODEL
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