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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION LITHOTRIPSY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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WILSON-COOK MEDICAL INC FUSION LITHOTRIPSY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number FS-LXB-3X6
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
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 prior to distribution, all fusion lithotripsy 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 a cook fusion lithotripsy extraction basket. It was reported that the first time into the common bile duct gravel failed [unable to break stone], and the front end of the basket suddenly broke [subject of report] in the second process of common bile duct during lithotripsy. The procedure was not completed successfully and abandoned. 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 NameFUSION LITHOTRIPSY EXTRACTION BASKET
Type of DeviceFFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
Manufacturer (Section D)
WILSON-COOK MEDICAL INC
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key15108209
MDR Text Key298294539
Report Number1037905-2022-00413
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-LXB-3X6
Device Lot NumberW4520346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2021
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: 07/26/2022 Patient Sequence Number: 1
Treatment
OLYMPUS 290 DUODENOSCOPE
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