MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MAJ-2027-E EC-S10 SET; ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET

Model Number MAJ-2027

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The subject maj-2027 has not returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject maj-2027 to determine the cause of this phenomenon when omsc receives it.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Before the capsule endoscopy, the user had confirmed that the recorder had received the capsule endoscopic image of the maj-2027 correctly, and then the patient ingested the subject maj-2027 to start the small intestinal capsule endoscopy.However, the image of the subject maj-2027 was not displayed even after about 30 minutes passed from the start of the capsule endoscopy.The physician retrieved the subject maj-2027 endoscopically and the capsule endoscopy was canceled.Even after retrieve, the image of the subject maj-2027 was not displayed.When the user turned off and on the subject maj-2027 by activator, the image was displayed.The battery was dead when the local staff of olympus received the subject maj-2027 from the user.There was no report of the patient¿s injury other than above.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2018-0115 to provide device evaluation results.The subject maj-2027 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc could not confirm the phenomenon.We consider probable causes below.We judge the failure occurred as the device was in other parts except small intestine.This product is for small intestine.The antenna sheet (maj-2031) was not set at correct position.(too high from the correct position).Although the antenna sheet was at correct position when put on, it moved by rolling over or other moving.During endoscope examination, the product was brought close to radio equipment, which caused interference of radio waves.Maj-2027 instruction manual states the corresponding method in case of an abnormality.

• Brand Name: MAJ-2027-E EC-S10 SET
• Type of Device: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7585484
• MDR Text Key: 110586369
• Report Number: 8010047-2018-01115
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• PMA/PMN Number: K123421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAJ-2027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1