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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event Description

It was reported by the area representative that a patient underwent an unspecified procedure using an ncircle tipless stone extractor.The report indicated that upon opening the product it was discovered to not be functioning properly.However, to complete the procedure another of the same product was used.No further information was provided, additionally questions have been sent to the customer for clarification.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, and quality control data, and visual inspection and functional testing of the returned device were conducted during the investigation.The device was returned with the unidex handle(udh) and the basket formation in the open positions.A functional test was performed and the udh was found to actuate the basket formation.A visual examination noted the basket formation had flattened smashed appearance.The support sheath was bent and a kink was observed in the basket sheath.A document-based investigation evaluation 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 shows no nonconforming events which could contribute to this failure mode.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.We will notify the appropriate personnel and continue to monitor 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: 6556507
• MDR Text Key: 74838537
• Report Number: 1820334-2017-00854
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)200210(10)7665726
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• 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-015115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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