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

Model Number SIF-H290S

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Olympus representative visited the user facility to obtain additional information including the outcome of the patient.However, the user facility refused to provide the information.The subject device was returned to omsc for evaluation.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.As the evaluation is in progress, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.The operation manual has already warned; this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner.Never insert or withdraw the insertion section abruptly or with excessive force.Patient injury, bleeding, and/or perforation may result.If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the endoscopy.Forcible insertion can result in patient injury, bleeding, and/or perforation.

Event Description

Olympus medical systems corp.(omsc) was informed that during an ercp (endoscopic retrograde cholangiography) procedure using the subject device, which intended to perform a metallic stent placement for stricture in the hepatic portal region of the patient, the intestinal tract of the patient was perforated.The patient had experienced a roux-en-y anastomosis procedure following gastric resection before the ercp procedure.In the early stages of the procedure, the user facility used the subject sif-h290s and an olympus splinting tube (st-sb1s); however, the sif-h290s could not pass through the anastomotic region, being unable to reach the papilla.Therefore, the user facility replaced them with another olympus small intestinal scope (sif-q260) and an olympus single use splinting tube (st-sb1), and inserted the sif-q260 and the st-sb1 up to the papilla.After that, the user facility removed the sif-q260 from the patient and cut a part at 15 cm from the proximal side of the st-sb1 with scissors, and then tried to insert the subject sif-h290s into the st-sb1.However, since the distal end of the st-sb1 was kinked at the intestinal anastomotic region, the sif-h290s could not be inserted.After forcibly straighten the kink, the user facility inserted the sif-h290s into the st-sb1 again.When the subject device was inserted through the st-sb1 into the patient, the user facility noticed by unusual endoscopic image that the distal end of the subject endoscope perforated the intestinal wall and came into the abdominal cavity.The user facility then aspirated intestinal fluids leaking into the abdominal cavity as much as possible using the sif-h290s and performed an emergency ct scan for the patient.The intended procedure was aborted.The user facility commented that the patient¿s perforation likely occurred since they pushed the kinked part of the st-sb1 too strong with the sif-h 290 s.Therefore, omsc submit the mdr regard with the sif-h290s and the st-sb1.This is a report on the sif-h290s (1 of 2 reports).

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The device evaluation confirmed that decreasing of the angulation range of the bending section, and too much play in the angulation mechanism.However, there were no malfunctions of the subject device such as leading to the perforation.

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7756299
• MDR Text Key: 116215656
• Report Number: 8010047-2018-01562
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-H290S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 50