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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The malfunction of the subject devices concerning this case has not been reported.Also, since the serial numbers of these devices are unknown, omsc could not confirm the manufacturing history.The exact cause of the reported event could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿current status in ercp procedure using balloon assisted endoscopes for reconstructed intestine¿ that was made in public in the 95th congress of the japan gastroenterological endoscopy society.The literature reported that the result of questionnaire survey for 161 cases of endoscopic retrograde cholangiopancreatography (ercp) procedure using a balloon endoscope for reconstructed intestine conducted at 13 facilities.It was reported that accidental symptoms occurred in 30 cases; 14 cases of pancreatitis, 9 cases of cholangitis, 6 cases of perforation, and one case of cholecystitis.One case of perforation required an emergency surgery to fixit.It was also reported that olympus and non-olympus balloon assisted enteroscope were used for these procedures.Omsc reviewed the delivery history of the endoscopes for the facilities and the history revealed that olympus balloon assisted enteroscope (model name: sif-q260, sif-h290s and sif-y0004-v01) had been delivered two user facilities which were surveyed.Since there was no information on the model and manufacturer of the balloon assisted enteroscope that was used in the 30 accidental symptom cases, omsc is submitting mdrs according to the number of the scope model of olympus.This is one of three reports.

• Brand Name: EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
• 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: 7577364
• MDR Text Key: 110332707
• Report Number: 8010047-2018-01069
• 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: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2018
• 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