MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET

Model Number	MAJ-2027
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Burning Sensation (2146); Caustic/Chemical Burns (2549); Weight Changes (2607); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician and patient informed olympus, the patient had the subject device procedure "a few months back" and having some issues.The physician reported the patient is reporting stomach burn.The patient reported she is allergic to iodotrotynyl butylcarbamate and thinks she is having a reaction to the subject device.She is having allergic blisters, redness, inflammation, and she is in pain.She went to the emergency room after two days of a burning stomach pain and diarrhea.She states her stomach is "on fire and aching 24/7." the patient states she has lost 11 pounds since this started.The patient reported the endocapsule has been inside of her for at least 18 days.She had x-ray imaging done on (b)(6) 2022 and the subject device was confirmed in the patient.On (b)(6) 2022, the patient had another x-ray image and it confirmed the subject device had passed and no longer inside the patient.

• Brand Name: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET
• Common Device Name: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 14464412
• Report Number: 2951238-2022-00408
• Device Sequence Number: 4596824
• Product Code: NEZ
• UDI-Device Identifier: 04953170328268
• UDI-Public: 04953170328268
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2022
• Report Date (Section F): 04/22/2022

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?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2022
• 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: Female