MAUDE Adverse Event Report: FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE FUJIFILM; DOUBLE BALLOON ENTEROSCOPE

Model Number EN-450T5/W

Device Problems Device Reprocessing Problem (1091); Misconnection (1399); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016, a fujifilm distributor visited the hospital and confirmed wrong tubing connection to the endoscope from a non-fujifilm reprocessing device and corrected the error.On 06/03/2016, hospital staff requested that fujifilm recommend a risk assessment method in order to follow up with patients on possible infection likelihood.On 06/09/2016, fujifilm proposed a comparative study on the amount of residual proteins after cleaning between proper tubing and improper tubing connection to an endoscope.As of 07/05/2016, there have been no reported patient infections.The distributor confirmed that other hospitals visited in his territory all have proper cleaning adapter connections.Fujifilm will inform applicable distributors on risks related to cleaning endoscopes using non-fujifilm cleaning devices.Due to existing (b)(6) practices in connection with local filings, the specific name and location of the initial reporter is not available.In this hospital, there are six fujifilm endoscopes: ultrasonic endoscope (quantity one), gastroscopes (oral type and transnasal type, two scopes each), and double-balloon endoscope (quantity one).For all six scopes, their adapters were found to have wrong tubing.Therefore, a total of six mdr's ( numbered 2431293-2016-00021 through 2431293-2016-00026) will be submitted.Reprocessing error; no endoscope defect.

Event Description

A technician at a hospital discovered tubing for an endoscope cleaning adapter was incorrect.The tube was connected to the suction channel inlet of the endoscope instead of the air/water channel inlet.As a result, cleaning/disinfecting chemicals failed to flush the air/water channel of the endoscope.

• Brand Name: FUJIFILM
• Type of Device: DOUBLE BALLOON ENTEROSCOPE
• 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: 5792115
• MDR Text Key: 49500213
• Report Number: 2431293-2016-00022
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• PMA/PMN Number: K040048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• 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?: No
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2011
• 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