MAUDE Adverse Event Report: COOK INC NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G32724
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: exempt.Investigation evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.One device returned to manufacturer for investigation.The returned packaging confirms the lot number.A visual examination noted that the device was returned with bio matter present indicating the device had been used.Visual examination notes a gap in the basket wires, the largest section of the gap measures approximately 2 mm.There are no broken or separated wires in the basket formation.A review of the device history record revealed no non-conformances related to the reported failure.A lot history search found no other complaints have been reported for this lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions users should be familiar with and experienced in urological endoscopic surgery.Assess calculi or other foreign bodies prior to instrument deployment to ensure that object is not too large to be removed through the anatomy.If resistance is encountered while attempting to remove calculi or other foreign bodies, release the object.Do not exert excessive force on the device.Due to the asymmetric nature of the ntrap, do not torque or rotate the device in vivo.A 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 cause for the observed issue could not be determined.It is possible the device was slightly damaged when removing it from the packaging, or possibly during use of the device.Per the quality engineering risk assessment, no additional risk mitigating activity is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It is reported prior to unspecified procedure using a ntrap stone entrapment and extraction device, the user opened the package and found "the basket seems not correct".This device was not used.A second basket of the same device type was used to complete the procedure.The patient did not experience any adverse effects as a result of this alleged product malfunction.

• Brand Name: NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE
• Common Device Name: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8741762
• Report Number: 1820334-2019-01542
• Device Sequence Number: 2534760
• Product Code: FFL
• UDI-Device Identifier: 00827002327245
• UDI-Public: (01)00827002327245(17)220109(10)9430345
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: G32724
• Device Catalogue Number: NTP-028145
• Device Lot Number: 9430345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1