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

Model Number	G22002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 no fluid in the catheter lumen.There is a small kink approximately 11.4 cm distal to the proximal end of the white shrink tubing.The distal tip of the catheter lumen is intact.One of the wires on the basket had broken loose from the proximal end of the basket and was still attached at the distal end of the basket.The basket wire was broken near the soldered joint; 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.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: 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 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 or Problem Description
In preparation for a procedure, the user selected a cook memory hard wire basket.The operator opened the package and checked the integrity before use.[it was] found that the "wire guide of the basket" was broken.The device was evaluated on (b)(6) 2018.It was determined that one of the wires on the basket had broken loose from the proximal end of the basket and was still attached at the distal end of the basket.

• Brand Name: MEMORY HARD WIRE BASKET
• Common Device Name: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7402272
• Report Number: 1037905-2018-00133
• Device Sequence Number: 13473662
• Product Code: FFL
• UDI-Device Identifier: 00827002220027
• UDI-Public: (01)00827002220027(17)191215(10)W3807100
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: G22002
• Device Catalogue Number: MWB-2X4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2018
• Device Age: 15 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1