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

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/21/2017
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
It was reported that prior to performing a retrograde intrarenal surgery (rirs) on a patient, the physician found that the tip of the ncircle tipless stone extractor basket could not be opened.The device did not come in contact with the patient.The physician completed the procedure by using another ncircle tipless stone extractor.
Additional Manufacturer Narrative
Investigation - evaluation: one ncircle tipless stone extractor was received for evaluation in opened package.A visual inspection noted the device was returned with the unidex handle (udh) and the basket formation both in the closed position.The basket sheath has been stretched up to 13.5 cm from the distal tip.A kink was noted in the basket sheath 88 cm from the distal tip.The polyethylene terephthalate tubing (pett) is 2.5 cm in length.The support sheath and the basket sheath were still adhered.Functional testing was performed and determined the udh handle does not actuate the basket formation.The collet knob is tight and secure.The udh handle was disassembled.The basket formation could not be manually activated.The basket sheath is smashed at approximately 1 cm from the distal end.The customer complaint has been confirmed.A definitive root cause could not be established.Based on the investigation evaluation, 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.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history found no other complaints associated with this device and lot number combination.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
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6629408
• Report Number: 1820334-2017-01311
• Device Sequence Number: 19064007
• Product Code: FFL
• UDI-Device Identifier: 00827002187771
• UDI-Public: (01)00827002187771(17)190602(10)7017981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NTSE-022115-UDH-MB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 63