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

Catalog Number NTSE-015115

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

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

The customer reported a (b)(6) patient was admitted for an ureteroscopy.As reported, the ncircle tipless stone extractor bent during the intervention.The basket misaligned towards the left.It was impossible to extract the stone with this extractor.Another device had to be used.As reported, there were no consequences to the patient but an increase of care time, because of the need to use another stone extractor.

Manufacturer Narrative

Investigation ¿ evaluation: the ncircle tipless stone extractor was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of the complaint history, the device history record, and quality control data was conducted.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.The device history record was reviewed and three (3) non-conformance issues were identified.The issues documented were shrink tube, damaged; tip/tapper, inadequate, incomplete or missing and seal, package, incomplete.The items were scrapped except for the two articles with the seal package issue which were reworked.A review of complaint history revealed there have been no other complaints associated with this complaint device lot number 7996359.Based on the provided information and the investigation evaluation a definitive root cause for the reported issue could not be determined.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.

Manufacturer Narrative

The complaint device was received for evaluation.A visual inspection and functional testing was performed.One device was returned for investigation.The device was returned with the handle and the basket formation in the closed position.The collet knob is tight and secure.The mlla (male luer lock adapter) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm.A functional test determined the handle actuated the basket formation.A visual examination noted the support sheath is bowed starting at the nose of the mlla.The tip of the basket sheath is bent 5mm from the distal tip; the bent tip causes the basket formation lean to the left.There is a kink in the basket sheath starting at 7 mm from the distal tip and again at 83.5 cm and 95 cm from the distal tip.The basket formation was noted to have 2 wires close together, allowing the basket formation to appear asymmetrical.The complaint device was found to have a basket that was not symmetrical due to sheath damage.The sheath was found to be bent and kinked in multiple locations, including near the distal end of the sheath, affecting the shape of the basket when open.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use of the device.The instructions for use (ifu) contains cautions about manipulating the device to prevent damage.There is no information related to device manipulation, therefore it could not be concluded that the device was damaged by the user.The root cause is unknown.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The complaint device was received for evaluation.A visual inspection and functional testing was performed.One device was returned for investigation.The device was returned with the handle and the basket formation in the closed position.The collet knob is tight and secure.The mlla (male luer lock adapter) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm.A functional test determined the handle actuated the basket formation.A visual examination noted the support sheath is bowed starting at the nose of the mlla.The tip of the basket sheath is bent 5mm from the distal tip; the bent tip causes the basket formation lean to the left.There is a kink in the basket sheath starting at 7 mm from the distal tip and again at 83.5 cm and 95 cm from the distal tip.The basket formation was noted to have 2 wires close together, allowing the basket formation to appear asymmetrical.The complaint device was found to have a basket that was not symmetrical due to sheath damage.The sheath was found to be bent and kinked in multiple locations, including near the distal end of the sheath, affecting the shape of the basket when open.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling/use of the device.The instructions for use (ifu) contains cautions about manipulating the device to prevent damage.There is no information related to device manipulation, therefore it could not be concluded that the device was damaged by the user.The root cause is unknown.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity 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
• MDR Report Key: 6976715
• MDR Text Key: 90437535
• Report Number: 1820334-2017-03618
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002462069
• UDI-Public: (01)00827002462069(17)200616(10)7996359
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NTSE-015115
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 DA