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

Model Number VP-4440HD

Device Problem Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

As reported by physician: in the middle of a colonoscopy, during which i removed a total of nine polyps, we lost all visualization and the screen went stark white.I froze in my position, the risk being that if i can't see, any movement i make could injure the colon.We were able to get the light source working again, however it was much dimmer than usual throughout the rest of the procedure.Additionally, scope buttons lost functionality.I was unable to freeze or capture images or change to fice.We were able to complete the procedure, and there were no untoward complications, gratefully.

Manufacturer Narrative

On 06/10/2015, the subject video processor was received at fujifilm medical systems endoscopy division.Upon inspection, it was observed the unit's video connector has corrosion due to residual fluid, as well as water residue around the top cover.The customer's claims of image loss and loss of endoscope button functionality are consistent with the inspection findings.The introduction of moisture, either by attachment of a wet endoscope connector or on the unit's main cover can damage the unit, potentially leading to image loss and endoscope malfunction.The customer will be re-inserviced on proper handling of endoscopic equipment.

• Brand Name: FUJINON
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section G): FUJIFILM OPTICS CO., LTD, MITO FACTORY; 4112 tono; hitachiomiya city ; JA
• Manufacturer Contact: john brzezinski ; 10 high point dr.; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 4905135
• MDR Text Key: 6835569
• Report Number: 2431293-2015-00008
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VP-4440HD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2012
• 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