MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOCAPSULE RECORDER

Model Number	RE-10
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned by the customer to date.The investigation is ongoing.A supplemental mdr will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
It was reported, the subject device displayed a 0135005-error message.There were no reports of patient harm.
Event or Problem Description
It was reported, the subject device displayed a 0135005-error message.There were no reports of patient harm.
Additional Manufacturer Narrative
Additional information/correction: d4-udi added, d9-device available for evaluation changed to no, h6: investigation codes updated.This event was reported in error.This is not a reportable malfunction and would not lead to a death or a serious injury if it were to recur.H10: the device was not returned, and the serial number was not available, therefore a device analysis was unable to be conducted.The cause could not be determined.

• Brand Name: ENDOCAPSULE RECORDER
• Common Device Name: ENDOCAPSULE RECORDER
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18899498
• Report Number: 3002808148-2024-31408
• Device Sequence Number: 12734359
• Product Code: NEZ
• UDI-Device Identifier: 04953170328244
• UDI-Public: 04953170328244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RE-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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
• Patient Sex: Unknown