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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Model Number G25149
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: olympus visiglide 0. 025inch wire guide. Investigation evaluation: our evaluation of the product said to be involved confirmed the report as it was described. The basket returned with a clear/white substance and yellow discoloration inside the tubing. The tip of the basket is protruding from the distal end of the sheath and appears to have a brown substance on it. The distal end of the sheath has a significant bend. The drive wire protrudes from the device proximal to the distal end of the purple shrink tubing. The purple shrink tubing is slightly damaged at the distal end. When the handle was manipulated, the exposed drive wire moved with the handle. When the distal end of the exposed drive wire was maneuvered, the basket emerged and retracted from the tip of the device about 6. 0 cm. Brown and black substance was present on the basket near the tip. A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis. 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. To prevent damage to the device, 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. " basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure. Resistance in basket extension and damage to the outer catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle. Prior to distribution, all memory ii double lumen 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 an extraction procedure, the physician used a cook memory ii double lumen extraction basket. After crushing stones, the extraction basket was advanced over a wire guide and the user extracted the remaining stones, however, the sheath was torn at the handle side during the second stone extraction with the device and basket wire(s) were exposed from the tear [drive wire ruptures through sheath]. The basket became unable to respond to handle manipulation so another cook extraction basket was used to complete the procedure. 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.
 
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Brand NameMEMORY II DOUBLE LUMEN 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 Key9268305
MDR Text Key219508452
Report Number1037905-2019-00661
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002251496
UDI-Public(01)00827002251496(17)220806(10)W4246250
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 10/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2022
Device Model NumberG25149
Device Catalogue NumberMB-35-2X4-8
Device Lot NumberW4246250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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