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

Model Number	SIF-Q180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Melena (4480); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On march 31, 2021, olympus medical systems corp.(omsc) received the literature titled "the role of single-balloon colonoscopy (sbc) for patients with previous incomplete standard colonoscopy: is it worth doing it?".This study was conducted on the single-balloon overtube-assisted colonoscopy for 100 patients from february 2008 to october 2014.In the literature, it was reported mucosal defect, severe abdominal pain, and hematochezia.The mucosal defect after the polypectomy was successfully closed with hemoclips, and the patient received prophylactic antibiotics and remained asymptomatic.Another patient suffered from severe abdominal pain and hematochezia after a diagnostic sbc without intervention.Computed tomography results excluded perforation.This outpatient was then admitted for medical observation and was discharged home pain-free after 4 days.Therefore, omsc assumes that the patient suffered from severe abdominal pain and hematochezia was an adverse event to submit due to hospitalization for medical observation.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.Omsc will submit one medical device reports (mdr) of the subject device for the adverse event need for severe abdominal pain and hematochezia.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Common Device Name: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11668524
• Report Number: 8010047-2021-04955
• Device Sequence Number: 19586916
• Product Code: FDA
• UDI-Device Identifier: 04953170242526
• UDI-Public: 04953170242526
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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
• Operator of Device: No Information
• Device Model Number: SIF-Q180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization