MAUDE Adverse Event Report: FUJIFILM OPTICS CO., LTD. MITO FACTORY FUJIFILM; VIDEO ENDOSCOPE

Model Number EG-L580NW

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

(investigation of usage history) the subject device was delivered as a loaner to the facility on 12/25/2015.In prior use as a loaner, it had been used for (b)(4) cases.(investigation of failure of the device) in the investigation of the device, a defect was found in the angle wire guiding part in the operating section.The principle of the endoscope's bending mechanism is that the bending section is curved (angulated) when the angle wire connected to this section is pulled.The failure occurred because the part guiding the angle wire was damaged, interrupting operation of the wire, thus preventing the bending section from returning to the neutral position.Because the same failure had not occurred previously, this event is considered as a very rare failure.The cause of damage to the angle wire and to its guiding part is now under investigation, however, one cannot rule out excessive force being applied by the user to the angle controls as a contributing factor.(check of the operation manual) the troubleshooting section of the operation manual addresses abnormalities found in the bending function (angulation system) and describes potential health hazards which may occur if the endoscope is removed forcibly.Users are instructed to immediately stop the procedure and to consult with their local fujifilm dealer in the event that the bending section doesn't return to its neutral position.Due to existing japanese practices in connection with local filings, the specific name and location of the initial reporter is not available.Although the subject device is not marketed in the u.S., this event is being reported in an abundance of caution and to ensure full compliance with the malfunction provisions of 21 cfr part 803.The company's investigation is ongoing.This mdr will be supplemented, as needed, once additional information is obtained.

Event Description

During a gastroscopic procedure, the angle knob was rotated in the up direction in the stomach to curve the bending section.Subsequently, the physician was not able to straighten the bending section while operating the knob, and the endoscope remained in the curved position.It was only possible to rotate the angle knob within a certain angle range without feeling a sense of resistance.The endoscope was then pulled out carefully without any patient injury.The physician used another endoscope to complete the examination without incident.

• Brand Name: FUJIFILM
• Type of Device: VIDEO ENDOSCOPE
• Manufacturer (Section D): FUJIFILM OPTICS CO., LTD. MITO FACTORY; 4112 tono; hitachiomiya city, 319-2 224; JA 319-2224
• Manufacturer (Section G): FUJIFILM OPTICS CO., LTD. MITO FACTORY; 4112 tono; hitachiomiya city, 319-2 224; JA 319-2224
• Manufacturer Contact: john brzezinski ; 10 high point drive; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 5503931
• MDR Text Key: 40429622
• Report Number: 2431293-2016-00017
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 02/16/2016

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
• Device Operator: Physician
• Device Model Number: EG-L580NW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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: VP-4450HD VIDEO PROCESSOR
• Patient Age: 64 YR
• Patient Weight: 60