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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, URETAL STONE DISLODGER

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COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, URETAL STONE DISLODGER Back to Search Results
Catalog Number MB-35-3X6-8
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: unknown. Investigation evaluation: our photo and laboratory evaluation of the product said to be involved confirmed the report. The device was returned with the basket completely extended out of the catheter lumen. Two (2) of the wires on the basket had broken loose from the proximal end of the basket but were still attached at the distal end of the basket. The basket extended and retracted freely with no sign of resistance, though the wires that detached remained outside of the catheter lumen. A silver fiber-like substance was detected near the proximal end of the basket and liquid was observed in the catheter. A meeting with production leadership was held, and the proximal tip of the wires were examined. It was determined that the wires had been damaged by the buff process. No part of the device was missing. No other anomalies were detected. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: it was confirmed that the device was broken due to damage on the basket wires caused by the buff process. This occurred due to operator error. Production management and the department team leads were notified of this occurrence. Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint. Prior to distribution, all memory ii double lumen extraction 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: 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), the physician used a memory ii double lumen extraction basket. The user captured the stone with the device and pulled the device toward the duodenal papilla. The user detected that the basket wire was broken [subject of report] after pulling the device out of duodenal papilla. The user changed to another one of the same devices to complete the procedure. 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 II DOUBLE LUMEN EXTRACTION 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 Key10553285
MDR Text Key207531297
Report Number1037905-2020-00389
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/22/2022
Device Catalogue NumberMB-35-3X6-8
Device Lot NumberW4195243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2019
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: 09/18/2020 Patient Sequence Number: 1
Treatment
ENDOSCOPE, UNKNOWN MODEL AND MANUFACTURER
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