MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET; ENDO CAPSULE

Model Number	MAJ-2027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for analysis.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304-2023-00197.
Event or Problem Description
The customer reported to olympus that the patient swallowed the cradle endo capsule and informed the staff they have a pacemaker.The patient was monitored for one hour and sent home with the instruction to monitor.The study was completed and results were obtained without any problems, and the patient was not harmed.
Additional Manufacturer Narrative
The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.There was no report related to the defect of the device.Based on the results of the investigation, cause of the event cannot be determined.The instructions for use include the following description which prohibits use of the subject device on the patients who use pacemakers: "contraindication this system is contraindicated to patients with the following conditions.Patients with cardiac pacemakers or other implanted electronic devices (e.G., defibrillators) cardiac pacemakers or other implanted electronic devices may malfunction due to the rf (radio frequency) interference." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being created as a correction.The following sections have been updated: d4 model number: maj-2027 this supplemental report has been submitted by the importer under this mdr report number 2429304 - 2023 - 00197-1.

• Brand Name: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET
• Common Device Name: ENDO CAPSULE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17176562
• Report Number: 3002808148-2023-06259
• Device Sequence Number: 6629925
• Product Code: NEZ
• UDI-Device Identifier: 04953170328381
• UDI-Public: 04953170328381
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2023

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: Health Professional
• Device Model Number: MAJ-2027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 09/04/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/28/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown