MAUDE Adverse Event Report: FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE FUJINON; VIDEO ENDOSCOPE

Model Number EN-450T5

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

In response to fda form 483 inspectional observation issued on april 9, 2015, fujifilm conducted a retrospective review on two year repair work orders to ensure repair records had been properly evaluated for mdr assessment in accordance with medical device reporting regulation under 21 cfr 803.As a result of the review, this repair report identifies the malfunction as a worst case failure that may have triggered "bending section is locked in a j-shape and cannot be released".However, because there is little information available on the underlying event which led to the repair, the company was unaware of the failure actually occurring.Therefore, this mdr is being submitted in an abundance of caution as a part of a retrospective review and remediation effort focused on service and repair records.No known patient injury or death resulted from this event.

Event Description

This mdr is being submitted in an abundance of caution as a part of a retrospective review and remediation effort focused on service and repair records.No known patient injury or death resulted from this event.

• Brand Name: FUJINON
• Type of Device: VIDEO ENDOSCOPE
• Manufacturer (Section D): FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE; 4112 tono; hitachiomiya city ibaraki, 319-2 224; JA 319-2224
• Manufacturer (Section G): FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE; 4112 tono; hitachiomiya city ibaraki, 319-2 224; JA 319-2224
• Manufacturer Contact: john brzezinski ; 10 high point drive; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 6517445
• MDR Text Key: 73620353
• Report Number: 2431293-2017-00019
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EN-450T5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1