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

Model Number N/A

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

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 during an intended transurethral stone removal procedure, the physician inserted an ncircle tipless stone extractor basket into an endoscope. The physician retrieved the pieces of crushed stones with the device after performing calculus fragmentation. After several attempts of stone retrieval, the physician noticed that the shaft of the device was kinked and separated. The physician used another device to complete the procedure. There was no patient harm reported and no additional procedures were required because of this failure.

Manufacturer Narrative

A review of the complaint history, device history record, quality control, specifications, and visual inspection of the returned device were conducted during the investigation. The physical evaluation of the device that was returned and it confirmed that the basket sheath was separated from the coil assembly. 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. A review of the device history record found 1 other non-conformance associated with the complaint device lot number 7756322 (difficult to advance thru sheath ). Based on the investigation, there is no indication that a design or process related failure mode contributed to this event. Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping. Additionally, a review of records found this complaint to be one of two complaints associated with lot 7756322. (b)(4) was for the same lot number, but the failure mode was different. Based on the provided information a definitive root cause cannot be established or reported at this time. Per the quality engineering risk assessment no further action is required.

• 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: 6665494
• Report Number: 1820334-2017-01433
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)200317(10)7756322
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention