MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SIF-Y0004; UNKNOWN

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

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

Olympus medical systems corp.(omsc) received a literature titled ¿bile duct stone treatment using short-sbe (single balloon endoscope) for patients who experienced intestinal reconstructive surgery¿.The literature reported the result of 151 cases of the bile duct stone treatment procedures using an olympus model sif-y0004 or sif-y0015 or sif-h290s between july 2013 and february 2019.7 cases of pancreatitis, 5 cases of cholangitis, a case of endoscopic perforation and a case of perforation during anastomotic expansion reportedly occurred during the period of the study.Available information suggested that at least one of the three olympus products has caused or may have contributed to the endoscopic perforation.Therefore, omsc is submitting three mdrs for the endoscopic perforation.This is 2 of 3 reports.If additional information indicates that olympus products have or may have contributed to the other complications, omsc will submit mdrs separately.

• Brand Name: SIF-Y0004
• Type of Device: UNKNOWN
• 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: 9501890
• MDR Text Key: 187772114
• Report Number: 8010047-2019-04487
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other