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

Catalog Number MB5-2X4-8

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 fluid in the catheter lumen.One of the wires on the basket had broken loose from the distal end of the basket and was still attached at the proximal end of the basket.The basket extended and retracted freely with no sign of resistance.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.The broken wire has a small hair-like substance at the end of the wire, and part of the basket has an unknown yellow substance on it.No other anomalies were detected.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 near the soldered joint.If excessive force is applied, basket breakage can occur near the soldered joint.Prior to distribution, all memory eight 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 and this represents an isolated occurrence.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

In preparation for a procedure, the user selected a cook memory eight wire basket.The user opened the package and found out that the basket wire was broken.It was not used on patient.

• Brand Name: MEMORY EIGHT WIRE BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• 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 Key: 10859899
• MDR Text Key: 243100960
• Report Number: 1037905-2020-00489
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002215389
• UDI-Public: (01)10827002215389(17)221209(10)W4295357
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2020

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 Date: 12/09/2022
• Device Catalogue Number: MB5-2X4-8
• Device Lot Number: W4295357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• 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