MAUDE Adverse Event Report: COOK INC WILLIAMS CYSTOSCOPIC INJECTION NEEDLE; FBK ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number 090001

Device Problems Structural Problem (2506); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/04/2016

Event Type  malfunction  

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 Description

It was reported an issue with cystoscopic injection needle which made the device unusable.It was further noted a longitudinal split on a dilator covered with an unknown substance.In addition, the hub was bent.There was no clinical consequences reported.

• Brand Name: WILLIAMS CYSTOSCOPIC INJECTION NEEDLE
• Type of Device: FBK ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 8116329
• MDR Text Key: 128903786
• Report Number: 1820334-2018-03580
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 00827002142206
• UDI-Public: (01)00827002142206(17)190217(10)6742775
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Catalogue Number: 090001
• Device Lot Number: 6742775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1