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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-2X4
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter; occupation: unknown. The investigation is on-going. A follow-up emdr will be provided.
 
Event Description
In preparation for an endoscopic retrograde cholangiopancreatography (ercp), the physician opened a memory hard wire basket and noticed that one basket wire was broken. Physician used another of the same device to complete the procedure. This occurred prior to patient contact; there was no impact to the patient.
 
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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
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key11118933
MDR Text Key255583534
Report Number1037905-2021-00002
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/13/2022
Device Catalogue NumberMWB-2X4
Device Lot NumberW4214165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2019
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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