MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE

Model Number UNKNOWN(SIF-Q260 OR SIF-H290S)

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject device has 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.There was no malfunction report of the subject device concerning the events.The exact cause could not be determined.

Event Description

On (b)(6) 2018, olympus medical systems corp.(omsc) received a literature titled ¿treatment result of endoscopic balloon dilation (ebd) for intestinal stenosis in crohn¿s disease¿ that was made in public in 26th japan digestive disease week.The literature reported the results and accidental symptoms in 93 procedures of ebd, which was conducted at the user facility and affiliated facility, for 29 crohn disease patients.It was also reported that the 2 cases of accidental symptom (perforation) occurred in the ebd procedures and the perforations were treated with unspecified surgery.Omsc reviewed the delivery history of the endoscopes and the history revealed that olympus small intestinal videoscopes (model sif-h290s, sif-q260) and single use splinting tube (st-sb1, st-sb1s) had been delivered to the user facility.Omsc tried to obtain additional information from the user facility, but additional information was not provided at present.Since there was no information on the model of the small intestinal videoscope that was used in the 2 cases, omsc is submitting two mdrs according to the number of reported perforation cases in small intestinal videoscope and two mdrs in splinting tube.This is two of two reports in small intestinal videoscope.

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE
• Type of Device: SMALL INTESTINALVIDEOSCOPE
• 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: 8114257
• MDR Text Key: 128722092
• Report Number: 8010047-2018-02314
• 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: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN(SIF-Q260 OR SIF-H290S)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2018
• 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