MAUDE Adverse Event Report: COOK INC N-COMPASS NITINOL STONE EXTRACTOR; GAE SNARE, SURGICAL

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Device is available for evaluation but has not yet been received by the manufacturer.Pma/510(k) #: exempt.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that on (b)(6) 2019, the basket of a n-compass nitinol stone extractor was unable to be opened.No adverse events or patient harm were reported at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: d10.Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One used n-compass nitinol stone extractor was returned for investigation.Upon a physical inspection, the device handle was noted to be in a partially opened position.The basket formation was noted to be retracted in the basket sheath.The male luer lock and collet knob were tight and secure.The handle was disassembled for observation.During a function test, the handle did not actuate the basket formation and could not do so manually.It was noted that the basket assembly could not be pulled out of the sheath and appeared to be stuck inside.No kinks were noted in the basket sheath and glue was visible near the cannulated handle.The distal end of the cannulated handle was found damaged.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record for lot 9743348 found no non-conformances.A lot history search found one other complaint recorded for this lot.A complaint was opened for a similar issue from the same customer (reported in mfg.Report reference #: 1820334-2019-02202).Investigation of devices from both complaints concluded the most likely cause for both complaints was that the devices were damaged due to handling, and not any product related issue that would indicate an issue with other devices in the lot.Cook has concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause could not be established.It is possible the device suffered handling damage during unpacking / handling that prevented the basket from opening once withdrawn into the sheath.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Type of Device: GAE SNARE, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8957954
• MDR Text Key: 157495805
• Report Number: 1820334-2019-02201
• Device Sequence Number: 1
• Product Code: GAE
• UDI-Device Identifier: 00827002362512
• UDI-Public: (01)00827002362512(17)220421(10)9743348
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-NTSE-2.4-115-NCT4
• Device Lot Number: 9743348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1