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

Model Number N/A

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

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 during preparation for an unspecified procedure the basket broke.Before the nurse was able to use the ngage nitinol stone extractor on the patient, the nurse noticed that the basket would not open or close.The handle to the ngage nitinol stone extractor did not work.No known impact to the patient; as the patient did not require any additional procedures due to this occurrence.No further information was provided.

Manufacturer Narrative

Additional narrative/investigation ¿ evaluation: a review of the following investigation methods were done on the returned device: functional test, review of complaint history, review of device history record, review of manufacturing instructions, review of quality control, and visual inspection.One stone extractor was returned for investigation.The device was returned with the handle in the closed position and the basket formation was in the open position.The collet knob was noted to be loose and partially unscrewed.There is a gap between the knob and the handle.The support sheath is adhered securely to the basket sheath.A visual examination of the device noted the basket sheath has a kink from the end of the support sheath.A functional test was performed and the unidex handle (udh) would not actuate the basket formation.The collet knob was tightened for investigational purposes and the udh handle was found to actuate the basket formation several times.The device history record was reviewed and no non-conformances were noted for reported lot number.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Measures have been previously initiated to address this issue.Quality engineering risk assessment (qera) was revised to address this issue.No further action is required.

• Brand Name: NGAGE NITINOL 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: 6518026
• MDR Text Key: 73572476
• Report Number: 1820334-2017-00833
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482944
• UDI-Public: (01)00827002482944(17)191103(10)7416130
• 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,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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: NGE-017115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• 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