MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-XQ260

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

Patient Problems Pulmonary Embolism (1498); Air Embolism (1697); Bradycardia (1751); Coma (2417); Low Oxygen Saturation (2477)

Event Type  Death  

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 lot 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 was no description of the device's malfunction.

Event Description

On april 26, olympus medical systems corp.(omsc) received the literature "fatal biliary-systemic air embolism during endoscopic retrograde cholangiopancreatography: a case with multifocal liver abscesses and choledochoduodenostomy¿.The purpose of the literature was to report a rare case of a massive fatal embolism that occurred in the middle of endoscopic retrograde cholangiopancreatography (ercp).In the literature, a massive cardiac and pulmonary air embolism originated from the biliary-venous fistula occurred and the patient died.The literature wrote as follows.A (b)(6) year-old female visited the emergency department with a 15-day history of epigastric pain, fever, chill, and nausea.The patient had a history of abdominal surgery for multiple biliary stones 20 years prior but was not able to recall detailed information.The patient complained of acute, continuous, dull-like pain, located in the epigastrium without any radiation, and, on a physical examination, the abdomen was soft but tender on the right upper quadrant area with no rebound tenderness.Initial laboratory test results were as follows: white blood cell count, 14,760mm3; hemoglobin level, 10.0 gdl; erythrocyte sedimentation ratio, 140 mmhr (normal range, 1-20 mmhr); c-reactive protein level, 23.89 mgdl (normal range, 0-0.3 mgdl); aspartate aminotransferase level (ast), 101 iul (normal range, 10-40 iul); alanine aminotransferase (alt) level, 114 iul (normal range, 5-40 iul); total bilirubin, 4.6 mgdl (normal range, 0.2-1.2 mgdl); amylase level, 48 ul (normal range 20-125 ul).An abdominal computed tomographic (ct) scan revealed the presence of multiple stones in the common bile duct (cbd) and intra-hepatic duct (ihd) with biliary obstruction, multifocal liver abscesses, and air-biliarygram.Emergency ercp was subsequently performed.On an initial examination, an opening of a choledochoduodenostomy, which may have been created at the previous surgery, was observed.Cholangiogram confirmed multiple filling defects in the cbd.Due to the presence of a wide and straight ostomy orifice and the marked dilatation of the cbd, with the use of a forward endoscope (gif-xq260, olympus, (b)(4)) we were able to commence the extraction of brown-pigmented mud stones without difficulty.In the middle of the procedure, the patient suddenly became hypoxic and bradycardic.The patient was soon comatose, and cardiac arrest developed.The procedure was immediately terminated and cardio-pulmonary resuscitation commenced followed by prompt intubation.The patient was transferred to the intensive care unit while resuscitation was continued.However, the patient died without restoration despite of all efforts.A chest xray taken at the scene suggested a massive systemic air embolism.The cause of death was thought to be a massive cardiac and pulmonary air embolism originated from the biliary-venous fistula.¿ the author said in the discussion, ¿another important factor (of a massive cardiac and pulmonary air embolism) is the wide opening of a choledochoduodenostomy.This broad and straight structure directly communicated with the intra-hepatic biliary ducts.It not only enabled us to remove the stones with a forward endoscope, but also allowed a push of a substantial amount of air and pressure into the hepatic venous circulation.Based on the available information, the endoscope might be associated with a massive cardiac and pulmonary air embolism originated from the biliary-venous fistula.

Manufacturer Narrative

We could touch with the second author, (b)(6) on (b)(6) 2021.According to dr.Kwon, "the patient was already got the ¿choledochoduodenostomy(cdd)¿ from surgery.That is why duodenum was opened as you can see in black mark.(nowadays, choledochojejunostomy technique is used yet cdd was performed 10 years ago) therefore, no need to use tjf scope for this case, he put endoscope into cbd directly to get remove multiple stones.He thinks that it was a kind of the first trial of dpoc.As for air function, the patient death was not related to endoscope function itself.It was related to doctors¿ awareness of air function in biliary tract.".

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11774045
• MDR Text Key: 248999146
• Report Number: 8010047-2021-05835
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GIF-XQ260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR