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 Death (1802)

Event Type  Death  

Manufacturer Narrative

The article did not specify the serial number of the referenced scope; therefore, it is unknown if the scope was returned for repair/service.An instrument history is unable to be performed.Furthermore, the study's physician provided a probable cause of the reported death stating that "it was hypothesized that the patient's death may have been due to air embolism, although a pulmonary embolism, mucus plug, arrhythmia, and myocardial infarction are also possibilities.Prolonged manipulation and endoscopy time may result in more leakage of air through a newly formed gastrostomy into the peritoneum.However, the jejunal extension insertion using a single-balloon enteroscope is actually faster than the standard technique because of the lack of retrograde migration, and thus it was felt that this did not contribute to the adverse outcome in this patient.".

Event Description

Olympus received an article titled ¿insertion of percutaneous endoscopic gastrostomy tubes with jejunal extensions using the ¿wedge¿ technique: a novel method to prevent retrograde tube migration into the stomach¿.There were 17 patients on the study.The article reported that two adverse events occurred due to peg insertion although none were related to the jejunal extension insertion itself using the wedge technique.One female patient developed asymptomatic pneumoperitoneum after the procedure.She was discharged 6 hours later when a repeat abdominal x-ray showed resolution of most of the free air.She remained asymptomatic until noon the following day when she took a nap with her husband, coughed once, and stopped breathing.Resuscitation was not performed, following the patient¿s prior wishes.An autopsy was offered but declined.This is patient 2 of 2 adverse events for the subject study.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer reviewed the contents of this complaint.The exact root cause of the reported event could not be determined.As there was no reported malfunction of the subject device related to the events.In addition, there was no proof/description to show the association between the adverse events and the subject device.

• 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
• MDR Report Key: 9849898
• MDR Text Key: 183972855
• Report Number: 8010047-2020-01816
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 04953170242526
• UDI-Public: 04953170242526
• Combination Product (y/n): N
• PMA/PMN Number: K071254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-Q180
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR