MAUDE Adverse Event Report: UNKNOWN UNKNOWN

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The malfunction of the subject device concerning this case has not been reported.Also, since the serial number of this device is unknown, olympus medical systems corp.(omsc) could not confirm the manufacturing history.Because the user facility recognized as accidental symptom in the conclusion of the report, this case is not the malfunction of device, it seems to be accidental symptom.But the exact cause of the reported event could not be conclusively determined.

Event Description

The following article was reported at (b)(6).Article title: the study of endoscopic bile duct calculus treatment using short-sbe for postoperative reconstructed intestinal tract cases.< report summary> the article stated that studied the clinical usefulness of endoscopic bile duct calculus treatment using short single balloon endoscope (short-sbe) for postoperative reconstructed intestinal tract cases.The target of this report are procedures of endoscopic retrograde cholangiopancreatography(ercp)-related procedures using short-sbe (products: sif-y0004, sif-y 0015, sif-h290s) from july 2013 to february 2017, and calculus treatment procedures using duodenoscope(jf group) during the same period.In the subject procedures, accidental symptoms occurred as follows.- short-sbe group: pancreatitis 6 cases, cholangitis 4 cases, perforation 2 cases.- jf group: accidental symptoms(details are unknown) 12 cases.[conclusion] accidental symptoms of treatment of bile duct calculus using short-sbe in the postoperative reconstructed intestinal tract was within acceptable range, and it was able to carry out safely in the same way as usual treatment of bile duct calculus using duodenoscope.This is 22 of 24 reports.(jf group: accidental symptoms(details are unknown) 10 of 12 reports.).

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWN
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6992347
• MDR Text Key: 90745419
• Report Number: 8010047-2017-01616
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2017

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: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other