MAUDE Adverse Event Report: COOK INC NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NTSED-024115-UDH-MB

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The user facility reported that the ncircle delta wire tipless stone extractor basket would not open prior to use on the patient.There was no patient contact with this device.There were no adverse consequences or effects to the patient reported due to this occurrence.Additional patient and event information was requested but not provided.

Manufacturer Narrative

Investigation - evaluation: a review of manufacturing instructions, specifications, the actual returned device, quality control data, and drawings was conducted during the investigation.The returned device was found to be fully closed, and the basket could not be opened, confirming the device was non-functional.Observed damage to the sheath was preventing the basket from opening.Current controls are in place in manufacturing to assure device functionality and integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.There is no indication that a design or process related failure mode contributed to this event.Based on available information, a definitive root cause can not be determined at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: NCIRCLE DELTA WIRE TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7008743
• MDR Text Key: 92512139
• Report Number: 1820334-2017-03914
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002191112
• UDI-Public: (01)00827002191112(17)191208(10)7502371
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: NTSED-024115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/20/2018
• Patient Sequence Number: 1