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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); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: non-healthcare professional.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
 
Event Description
During an endoscopic procedure, the physician used a cook memory hard wire basket.The physician could not push the basket out of the sheath with several attempts which caused the sheath to deform.Another wire basket was used to complete the procedure.Photos received from the customer depicted the handle was detached from the device.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.
 
Manufacturer Narrative
Continued: section e.Initial reporter occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved and the photo of the handle disconnected from the drive wire cable confirmed the separated drive wire.The device was returned with the basket fully retracted into the sheath.The handle was detached from the catheter and drive wire cable.The weld joint at the end of the proximal end of the handle cannula and the solder joint at the distal end of the cannula failed which allowed the handle to detach.For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and the drive wire cable and drive wire cannula were discolored near the intended joint location.A small metallic ball of solder fell out of the white hub.The welded ball was present at the proximal end of the drive wire.The loose solder ball is likely from the joint between the handle cannula and the drive wire cable.There is no solder remaining on the cannula, however there is evidence the cannula was buffed after the solder process.No other anomalies were detected with the devices.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: the solder and weld joint failures caused the basket handle to detach.The cause of the joint failures is unknown.Evidence of a manufacturing nonconformity was not observed.The solder and weld joint failures can occur if the device experiences excessive pressure during use.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 procedure, the physician used a cook memory hard wire basket.The physician could not push the basket out of the sheath with several attempts which caused the sheath to deform.Another wire basket was used to complete the procedure.Photos received from the customer depicted the handle was detached from the device.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 Name
MEMORY HARD WIRE BASKET
Type of Device
FFL, URETAL STONE DISLODGER
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key9641679
MDR Text Key200810847
Report Number1037905-2020-00047
Device Sequence Number1
Product Code FFL
UDI-Device Identifier10827002220024
UDI-Public(01)10827002220024(17)220909(10)W4258692
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/09/2022
Device Catalogue NumberMWB-2X4
Device Lot NumberW4258692
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Initial Date Manufacturer Received 01/02/2020
Initial Date FDA Received01/29/2020
Supplement Dates Manufacturer Received01/29/2020
Supplement Dates FDA Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ENDOSCOPE, UNKNOWN MAKE OR MODEL.
Patient Age45 YR
Patient Weight50
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