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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY WEB II MEMORY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Model Number G22303
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/28/2019
Event Type  Injury  
Manufacturer Narrative
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 (ifu) states: "this device should never be coiled in less than an 8-inch (20 cm) diameter. " the instructions for use (ifu) states: "confirm desired position of basket sheath relative to target. Advance basket out of sheath. Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable. " prior to distribution, all web ii memory extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity. A review of the possible device history records 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 a stone retrieval procedure, the physician used a cook web ii memory extraction basket. Once the stone was retrieved, and the nurse started to close the basket, the plastic sheath broke near the handle, thus it was not possible to extract the basket nor the stone. Part of the wires of the basket came out and it was not possible to re-open the basket. They cut the handle to remove the endoscope. The patient had to undergo surgery to remove it [the basket and biliary stone]. The extraction basket remained inside the patient¿s body. The patient required surgery to remove the basket and biliary stone due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameWEB II MEMORY 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 Key8833404
MDR Text Key152459014
Report Number1037905-2019-00425
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002223035
UDI-Public(01)00827002223035(17)210627(10)W4082008
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/27/2021
Device Model NumberG22303
Device Catalogue NumberMSB-35-2X4
Device Lot NumberW4082008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2018
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: 07/26/2019 Patient Sequence Number: 1
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