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

Model Number G25149

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report of the broken handle and determined the drive wire was broken.The device was returned with the tabs on the handle broken and the handle extended past the handle insert.The basket was returned pulled back into the catheter at 0.8 cm.For further evaluation the handle was pulled out of the insert.It was noted that the drive wire cable has separated from the handle cannula.The portion of drive wire cable remaining attached to the handle cannula has nested (bunched up against the handle cannula).Solder is still on the handle cannula of the joint.For further evaluation of the drive wire cable and basket, the catheter was cut to pull/push the drive wire cable out of the sheath.No discrepancies were noted with the basket.The drive wire cable has nested (bunched up).There is also a slight bend on the distal end of the catheter.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position, or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use states: "confirm desired position of basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable." the instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.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.Our laboratory evaluation of the product said to be involved confirmed the report of the broken handle and determined the drive wire was broken.The device was returned with the tabs on the handle broken and the handle extended past the handle insert.The basket was returned pulled back into the catheter at 0.8 cm.For further evaluation the handle was pulled out of the insert.It was noted that the drive wire cable has separated from the handle cannula.The portion of drive wire cable remaining attached to the handle cannula has nested (bunched up against the handle cannula).Solder is still on the handle cannula of the joint.For further evaluation of the drive wire cable and basket, the catheter was cut to pull/push the drive wire cable out of the sheath.No discrepancies were noted with the basket.The drive wire cable has nested (bunched up).There is also a slight bend on the distal end of the catheter.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position, or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use states: "confirm desired position of basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable." the instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.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

In preparation for a procedure, the user selected a cook memory ii double lumen extraction basket.Before the stone extraction [procedure], the nurse tried to check the basket which worked properly.However, the handle of the basket was broken when she actuated it.The device was evaluated on 11/20/2017.The evaluation found that the handle was disconnected from the drive wire [drive wire breakage].

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Type of Device: FFL, URETAL STONE DISLODGER
• Manufacturer (Section D): 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 Key: 7120909
• MDR Text Key: 95915888
• Report Number: 1037905-2017-00758
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)200227(10)W3828723
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G25149
• Device Catalogue Number: MB-35-2X4-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2017
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1