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

Catalog Number	NTHSES-030115-UDH
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user facility representative reported, during an ureteroscopic lithotripsy (ursl) procedure when the physician tried to use the ncircle helical tipless stone extractor to grab the stone, the basket wouldn't close.A new basket was opened and used to complete the procedure.There were no adverse consequences to the patient because of this occurrence.
Additional Manufacturer Narrative
Evaluation / investigation.A visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, documentation, drawings, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned in used condition with the handle in the closed position and the basket formation in the open position.The collet knob is tight and secure.The male lure lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 2 cm in length.A visual examination noted the basket sheath and the support sheath have become detached; minimal adhesive was noted on the basket sheath.The returned device was found to be non-functional due to the sheath separating from the handle.Device are 100% tested for proper operation after manufacturing.It is possible that insufficient glue was applied to the sheath joint during manufacturing, causing the sheath to separate during use.It cannot be confirmed that insufficient glue was applied as there are other potential causes for the observation of minimal adhesive: there may have been an issue with the glue curing process, or the glue may have come off after the sheath separated.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.The device history record was reviewed and noted there were no non-conformances related to the reported failure mode.A review of complaint history revealed this is the only reported complaint associated with the complaint lot number 7940888.The root cause of this event is manufacturing related; process related.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 HELICAL TIPLESS STONE EXTRACTOR
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6906761
• Report Number: 1820334-2017-03426
• Device Sequence Number: 13818214
• Product Code: FFL
• UDI-Device Identifier: 00827002181915
• UDI-Public: (01)00827002181915(17)200525(10)7940888
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: NTHSES-030115-UDH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 02/15/2018
• Patient Sequence Number: 1