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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
Model Number G22776
Device Problems Fracture (1260); Mechanical Jam (2983)
Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: lithotriptor, unknown make and model. Occupation: non-healthcare professional. 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. 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: 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 endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook the web extraction baskets. The ercp with wide papillotomy was performed, showing the outflow of purulent material. Cholangiopancreatography demonstrated compacted calculus in the distal third of the bile duct. They passed the extractor basket, with impaction of this (sic). The user attempted lithotripsy with lithotripter, with extractor basket breaking. A new basket was used and it broke in the biliary tract. After numerous attempts to withdraw, we decided to suspend the procedure and indicate emergency laparotomy. The broken basket remained inside the patient¿s body. The patient was taken to surgery for an emergency laparotomy to have the basket removed. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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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 Key8928096
MDR Text Key160221113
Report Number1037905-2019-00495
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002227767
UDI-Public(01)00827002227767(17)220307(10)W4188387
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2022
Device Model NumberG22776
Device Catalogue NumberWEB-2X4
Device Lot NumberW4188387
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2019
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: 08/23/2019 Patient Sequence Number: 1
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