MAUDE Adverse Event Report: COOK INC ENDOSCOPIC CHOLANGIOGRAPHY SET; GBZ CATHETER, CHOLANGIOGRAPHY

Catalog Number	ECS-500-TUOHY
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2015
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 during the patient's cholangiography, approximately 5 cm of the end of the 5 fr catheter "sheared" off when removing from the tuohy needle.Per the manufacturer's representative, "i believe the event occurred outside the patient and i was advised that there was no impact on the patient".No part of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence.No adverse effects to the patient were reported due to this occurrence.

• Brand Name: ENDOSCOPIC CHOLANGIOGRAPHY SET
• Common Device Name: GBZ CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6935321
• Report Number: 1820334-2017-03381
• Device Sequence Number: 10949137
• Product Code: GBZ
• UDI-Device Identifier: 00827002031968
• UDI-Public: (01)00827002031968(17)180306(10)5702282
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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 Catalogue Number: ECS-500-TUOHY
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1