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

Model Number EI-530B

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation of this incident shows the foreign object, which is a black tube approximately 40mm long, is not part of the endoscope.It is assumed to be part of an endotherapy device used in combination with the endoscope.Having investigated possible endotherapy devices used for dbercp, we identified that the foreign object is a tube (probably a heat shrinkable tube) that is equipped at the base of the control portion (the section between the control portion and the insertion portion) of disposable triple-lumen papillotome, v-system (certification no.(b)(4)) from another medical device manufacturer, judging from the remarkable similarity in the length and shape of the tube on the accessory compared to the subject tube.The length between the instrument channel inlet and the instrument channel outlet of the scope is about 1675 mm, so the papillotome (working length of 1700 mm) is not long enough to allow the knife portion to extend from the distal end of the scope during use (it requires a minimum extension of 23 mm from the scope).In this combination, a doctor may be operating the papillotome with its control portion (tube) pushed into the scope.Then, removing the papillotome from the scope may cause the detachment of the tube, leaving the tube within the instrument channel inlet.We reproduced this situation by experiment.It is therefore probable that the subject tube found in the scope originated from the papillotome components.No abnormality was found in the entire instrument channel of the endoscope.This endoscope model specifies compatible endotherapy devices having a working length of 2000 mm or longer, so the papillotome (working length of 1700 mm) is not compatible.The package insert of the papillotome states compatible endoscopes should be no longer than 1400mm.Therefore, this model endoscope is not compatible.The hospital of this incident did not use a papillotome during the examination, so the tube of the papillotome had remained in the scope previous to this incident.The endoscope, a loaner device from a distributor, was installed at the hospital on (b)(6) 2016 and used for the first time there on (b)(6).The tube was left behind in the scope somewhere in the previous facilities before it was installed at this hospital.This endoscope (loaner device) was last repaired in (b)(6) 2016, and then loaned to four hospitals before installation at this hospital.The use conditions at the four hospitals are under investigation.In order to potentially prevent any future similar occurrences and detect foreign objects in the instrument channel, the addition of a passage test using a ball gauge will be performed at fujifilm's service centers in (b)(4) before installing loaner devices.Fujifilm will also investigate the hospital where the scope was used with the papillotome to identify the patient status in terms of infectious disease.The result of the investigation will be shared with the hospitals where the loaner scope was used after the foreign tube was lodged in the endoscope.Further action will be determined by investigation results.Due to existing (b)(6) practices in connection with local filings, the specific name and location of the initial reporter, as well as the patient name are not available.This event is being reported in an abundance of caution and to ensure full compliance with the malfunction provisions of 21 cfr part 803, although the scope model ei-530b, used during this incident, is not a device that is marketed and sold in the u.S.

Event Description

During an endoscopic retrograde cholangiopancreatography procedure using a double-balloon enteroscope (dbercp), the doctor felt something strange when inserting a stent through the instrument channel inlet.The doctor advanced the stent and found a foreign matter, a black rubber tube, exiting the instrument channel outlet at the distal end of the enteroscope.After stent placement, the foreign matter was collected using the enteroscope, and then the examination was finished.

• 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: 5793744
• MDR Text Key: 49513428
• Report Number: 2431293-2016-00027
• Device Sequence Number: 1
• Product Code: FDA
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EI-530B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2011
• 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
• Treatment: VP-4450HD VIDEO PROCESSOR
• Patient Outcome(s): Other
• Patient Age: 65 YR