MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN; SMALL INTESTINAL VIDEOSCOPE

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

On may 11, 2018, olympus medical systems corp (omsc) received a literature titled ¿safety and efficacy of endoscopic bile duct stone treatment procedure for elderly people who experienced intestinal reconstructive surgery.¿ that was made in public in the 95th congress of the japan gastroenterological endoscopy society on may 2018.The literature reported the result of 186 cases (285 procedures) of endoscopic bile duct stones treatment using single balloon endoscopy (sbe) for the elderly people between january 2007 and september 2017.In the subject procedures, accidental symptoms reportedly occurred as follows; pancreatitis occurred in 9 procedures.Intestinal perforation occurred in 5 procedures.Cholangitis occurred in 5 procedures.Bleeding occurred in 3 procedures.Leakage pancreatic juice occurred in 1 procedure.Bile duct perforation occurred in 1 procedure.The literature concluded that, it was suggested that the procedure can be performed safety and effectively for even if the patient was elderly people (more than 75 years old) who experienced intestinal reconstructive surgery.Omsc reviewed the delivery history of the endoscopes (sbe type) and the history revealed that olympus small intestinal videoscopes (sif-y0004, sif-y0004-v01, sif-y0015, sif-h290s, sif-q260) had been delivered to the facility.Olympus is submitting mdr according to the number of procedural accidents case because it was not informed which endoscope model was used in the procedures.This is 15 of 24 reports.

• Brand Name: UNKNOWN
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7577274
• MDR Text Key: 110329366
• Report Number: 8010047-2018-01053
• Device Sequence Number: 1
• Product Code: FDA
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• 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