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

Model Number EN-450T5/W

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the returned endoscope, the distal bending section was locked in an angled position due to a defect found in the bending mechanism of the control section.According to the physician, the bending section was broken during the endoscopic examination, but angulation lock did not occur during the examination.It is likely that the angulation lock occurred sometime after completion of the examination.This is reported because there is a risk of health hazard if the angulation lock occurs during an examination and the device is removed forcibly.The operation manual describes the countermeasure for locked angulation on an endoscope.The subject endoscope model en-450t5/w is not marketed and sold in the united states.A similar model, en-450t5, is used in the u.S.Both models are similar in mechanical function and design.However, they differ in image field of view and observation range.No patient information available.Issue was identified while servicing the subject endoscope.

Event Description

Double balloon endoscopy examination was performed on a patient with obscure gastrointestinal bleeding (ogib).After reaching a deep part of small intestine, the endoscope's bending operation for down angulation was attempted, however the bending section did not bend.As there was still some observation range to be examined, the examination was continued using bending operation of right/left directions and completed.No health hazard to the patient.

• Brand Name: FUJIFILM
• 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: 5682452
• MDR Text Key: 46021246
• Report Number: 2431293-2016-00020
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EN-450T5/W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2005
• 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
• Treatment: LL-4450 LIGHT SOURCE