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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 G22776
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report as it was described. The drive wire has ruptured through the catheter on the proximal end of the device. The drive wire protrudes from the device proximal to the distal end of the purple shrink tubing. When the handle was manipulated, a slight resistance was felt initially and 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 3. 5 cm. The basket appears to be bent but not broken. A brownish/yellowish fluid was found throughout the device. 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. 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 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 removal procedure, the physician used a cook web ii memory extraction basket. After several passes, the basket became difficult to close. The nurse used force to close the basket, [and] where [sic] one of the wires appeared to come though the catheter [sheath]. No contrast could be used as hole presented in lumen of the device catheter [drive wire comes through sheath]. 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 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 Key8833724
MDR Text Key152408809
Report Number1037905-2019-00426
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002227767
UDI-Public(01)00827002227767(17)220123(10)W4170838
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/13/2019
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/23/2022
Device Model NumberG22776
Device Catalogue NumberMSB-35-2X4
Device Lot NumberW4170838
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2019
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: 07/26/2019 Patient Sequence Number: 1
Treatment
OLYMPUS DUODENOSCOPE, UNKNOWN MODEL
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