MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CRADLE

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
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.
Event or Problem Description
This report is being supplemented to provide the correct model number: maj-2027.New information added to the following field: d4.

• Brand Name: CRADLE
• Common Device Name: CRADLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 17176411
• Report Number: 2429304-2023-00197
• Device Sequence Number: 12324454
• Product Code: NEZ
• UDI-Device Identifier: 04953170328381
• UDI-Public: 04953170328381
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023
• Report Date (Section F): 05/22/2023

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?: Yes
• Distributor Facility Aware Date: 05/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown