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

Model Number EN-450T5/W

Device Problem Inflation Problem (1310)

Patient Problem Bowel Perforation (2668)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

The subject endoscope and balloon pump were evaluated and found to be operating normally.Investigation is underway to identify the root cause of the adverse event.The subject endoscope model en-450t5/w is not marketed or sold in the united states, however a similar device, model en-450t5, is used in the u.S.Market.Due to existing (b)(6) practices in connection with local filings, the specific name and location of the initial reporter are not available.Due to the ongoing investigation to identify root cause of the adverse event, any additional information will be provided in a supplemental mdr.Currently, two mdr's (numbered 2431293-2016-00034 through 2431293-2016-00035) are being submitted for the two devices (endoscope and overtube) that could have contributed to the event.

Event Description

(b)(6) 2016: a double balloon endoscopy procedure was performed on the patient.The endoscope reached the small intestine and then the physicians discovered the endoscope balloon stopped inflating.The physicians then used a syringe instead of the balloon controller to actuate the inflation/deflation of the balloon and complete the examination.(b)(6) 2016: the patient complained of abdominal pain.A ct scan was performed and a perforation was discovered.The patient underwent emergency surgery and an artificial anus was created at the perforated site of the small intestine for excretion.As of (b)(6), the patient was under observation, having moved from icu to a general ward.

Event Description

On (b)(6) 2016: a double balloon endoscopy procedure was performed on the patient.The endoscope reached the small intestine and then the physicians discovered the endoscope balloon stopped inflating.The physicians then used a syringe instead of the balloon controller to actuate the inflation/deflation of the balloon and complete the examination.On (b)(6) 2016: the patient complained of abdominal pain.A ct scan was performed and a perforation was discovered.The patient underwent emergency surgery and an artificial anus was created at the perforated site of the small intestine for excretion.As of august 1, the patient was under observation, having moved from icu to a general ward.

Manufacturer Narrative

On 12 dec 2019 fujifilm medical systems u.S.A., inc (fmsu) was notified by the fda that the follow up was submitted with incorrect sequence numbers (originally follow-up information was submitted under 2431293-2016-00036).Additional updates: b6- n/a.D3- manufacturer has been re-registered under fujifilm corporation.D4- indicated n/a for fields that are not applicable, udi- unknown.E1-e4- unknown.G1, g2- updating to include the current contact for the manufacturer.H6- conclusion code 14 (device incorrectly prepared for use or modified) and 71 (no failure detected, device operated within specification) is no longer available in the fdas code database.If any additional relevant information is provided, a supplemental report will be submitted.H10 information as submitted in the follow-up report 2431293-2016-00036: the subject endoscope and balloon pump were evaluated and found to be operating normally.Because no device abnormalities were detected, it is considered that the inflation/deflation failure occurred due to an incorrectly positioned balloon on the endoscope which slipped out of place during the procedure.The reason the balloon could be inflated but not deflated with the syringe was that the balloon shifted slightly and plugged the channel opening, acting like a check valve.(cause of the perforation) from a hearing with the hospital, it was determined that air supply was performed excessively by a male nurse using a 50ml syringe.Therefore, it is considered that the perforation was caused by the excessive air supply with the syringe and an overinflated balloon.The investigation result was reported to the medical safety management division and the endoscope division of the hospital.The hospital's endoscope division staff was trained on proper balloon mounting, and after three month's time, there have been no further similar occurrences.The subject endoscope model en-450t5/w is not marketed or sold in the united states, however a similar device, model en-450t5, is used in the u.S.Market.Due to existing japanese practices in connection with local filings, the specific name and location of the initial reporter are not available.This mdr is a follow up to previously submitted reports numbered 2431293-2016-00034 and 2431293-2016-00035.

• Brand Name: FUJIFILM
• Type of Device: DOUBLE BALLOON ENDOSCOPE
• Manufacturer (Section D): FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE; 4112 tono; hitachiomiya city, 319-2 224; JA 319-2224
• MDR Report Key: 5890944
• MDR Text Key: 52607994
• Report Number: 2431293-2016-00034
• 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,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EN-450T5/W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GW1 CO2 INSUFFLATOR; GW1 CO2 INSUFFLATOR; PB-20 BALLOON PUMP; PB-20 BALLOON PUMP; TS-13140 OVERTUBE; TS-13140 OVERTUBE; TY-04 TUBING FOR PB-20 PUMP; TY-04 TUBING FOR PB-20 PUMP; VP-4400 VIDEO PROCESSOR; VP-4400 VIDEO PROCESSOR; XL-4400 LIGHT SOURCE; XL-4400 LIGHT SOURCE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR