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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY MEMORY EIGHT WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number MB5-2X4-8
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation: unknown. Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. The device was returned with the basket fully extended out of the catheter lumen. There was fluid in the catheter lumen. One of the wires on the basket had broken loose from the distal end of the basket and was still attached at the proximal end of the basket. The basket extended and retracted freely with no sign of resistance. There was no evidence of the wire being damaged by the buff process. The basket was intact and no part of the device was missing. The broken wire has a small hair-like substance at the end of the wire, and part of the basket has an unknown yellow substance on it. No other anomalies were detected. Investigation conclusion: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting. This limits our ability to conclusively determine a cause. A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product. The basket wire broke near the soldered joint. If excessive force is applied, basket breakage can occur near the soldered joint. Prior to distribution, all memory eight wire 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 and this represents an isolated occurrence. 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
In preparation for a procedure, the user selected a cook memory eight wire basket. The user opened the package and found out that the basket wire was broken. It was not used on patient.
 
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Brand NameMEMORY EIGHT 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 Key10859899
MDR Text Key243100960
Report Number1037905-2020-00489
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 distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMB5-2X4-8
Device Lot NumberW4295357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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