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

Catalog Number	C-NTSE-2.4-115-NCT4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the n-compass nitinol basket would not open or close.A new basket was used to complete the procedure.It was further noted that the basket sheath had the appearance of being accordion 2 mm from the support sheath and it was also noted the basket formation had a broken wire.There were no adverse effects to the patient reported.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Common Device Name: GAE SNARE, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8167883
• Report Number: 1820334-2018-03820
• Device Sequence Number: 1446999
• Product Code: GAE
• UDI-Device Identifier: 00827002362512
• UDI-Public: (01)00827002362512(17)180801(10)4469254
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2018

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 Expiration Date: 08/01/2018
• Device Catalogue Number: C-NTSE-2.4-115-NCT4
• Device Lot Number: 4469254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1