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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY HARD WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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COOK ENDOSCOPY MEMORY HARD WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number MWB-3X6
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
This investigation is ongoing. The device was received at the time of this report. A follow up report will be sent.
 
Event Description
In preparation for a procedure, the user selected a cook memory hard wire basket. The physician opened the package and opened the basket checking the functionality and found that one of the basket wires detached. This occurred prior to patient contact; there was no impact to the patient. In addition, the user sustained no clinical consequence and there were no adverse effects to the user.
 
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Brand NameMEMORY HARD WIRE 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
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key12960981
MDR Text Key286351011
Report Number1037905-2021-00669
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,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMWB-3X6
Device Lot NumberW4350615
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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