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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY MEMORY HARD WIRE BASKET FFL, URETAL STONE DISLODGER Back to Search Results
Catalog Number MWB-2X4
Device Problems Fracture (1260); Solder Joint Fracture (2324)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation. The lot number provided in the photos matches this report. The label in the photo matches the product reported. The report was confirmed based on the pictures provided. The photo provided shows one of the wires on the basket has broken loose from the proximal end of the basket. The basket wire was broken near the soldered joint, but the wire is still attached to the distal end of the basket. The basket appears intact and no part of the device seems to be missing based on the photos. No other anomalies were detected. 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. In the pictures supplied from the user, the basket wire appears to have broken at the soldered joint. If excessive force is applied, basket breakage can occur near the soldered joint. Prior to distribution, all memory hard 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. 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) procedure, the physician used a memory hard wire basket for bile duct stone removal. The user advanced the device to the bile duct and detected the proximal basket wire detached before stone removal. 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 NameMEMORY HARD WIRE BASKET
Type of DeviceFFL, URETAL STONE DISLODGER
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 Key10038807
MDR Text Key222132231
Report Number1037905-2020-00202
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMWB-2X4
Device Lot NumberW4272018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2019
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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