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

Model Number SIF-Q180

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

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "single-balloon enteroscopy in management of small-bowel disorders".The literature reported the result of 158 patients with small-bowel disorders who underwent device-assisted enteroscopy including single-balloon enteroscopy (sbe) procedure using the olympus sif-q180 from december 2016 to december 2019.In the literature, it was reported complication as follows; bleeding (3 cases) : managed conservatively.Mild acute pancreatitis (2 cases) : symptomatic treatment.Jejunal perforation (1 case) : requiring surgical intervention.There are not mentioned that these complications were related to the subject device in question.However, omsc assumes that "jejunal perforation" might be related to the subject device and the literature states required surgical intervention.Therefore, omsc assumes that "jejunal perforation" was might be caused or contributed to a death or serious injury.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.From the above, omsc determined that the "jejunal perforation" was adverse events to submit.Omsc will submit a medical device report (mdr) of the subject device for the "jejunal perforation".

• Brand Name: EVIS EXERA II 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: 12375354
• MDR Text Key: 268506798
• Report Number: 8010047-2021-10803
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 04953170339943
• UDI-Public: 04953170339943
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2021

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: No Information
• Device Model Number: SIF-Q180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/26/2021
• 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): Required Intervention