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U.S. Department of Health and Human Services

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

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WILSON-COOK MEDICAL INC THE WEB EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number WEB-3X6
Device Problems Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 06/19/2022
Event Type  Injury  
Event Description
During a procedure to remove a cbd stone from the duodenum, the physician used the web extraction basket. It was reported that when tried to remove the stone by moving the basket handle, the tip of the basket hit the duodenum, causing perforation in the patient. The procedure was finished after hemostasis with a clip on the perforated area. A section of the device did not remain inside the patient¿s body.
 
Manufacturer Narrative
The product was returned for evaluation and the investigation is on-going. A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.
 
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Brand NameTHE WEB 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 Key15020529
MDR Text Key295953132
Report Number1037905-2022-00391
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
PMA/PMN Number
K171969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberWEB-3X6
Device Lot NumberW4365192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2020
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: 07/14/2022 Patient Sequence Number: 1
Treatment
OLYMPUS TJF 260V
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