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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/30/2017

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

It was reported that prior to performing an ureteroscopy (urs) procedure, the physician found that the handle of an ncircle tipless stone extractor basket was not working properly.The device did not come in contact with the patient and there was no patient harm reported.

Manufacturer Narrative

Investigation ¿ evaluation: the ncircle tipless stone extractor was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and one non-conformance was noted for the basket/grasper will not open/close.A review of complaint history revealed there have been no other complaints associated with complaint device lot number 7688659.Measures have been initiated to address this failure mode.Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined.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 TIPLESS STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6654452
• MDR Text Key: 78050069
• Report Number: 1820334-2017-01513
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002176270
• UDI-Public: (01)00827002176270(17)200220(10)7688659
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

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 Model Number: N/A
• Device Catalogue Number: NTSE-030115-UDH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/20/2017
• Date Device Manufactured: 02/20/2017
• 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