MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE EMR KIT

Model Number	K-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that during an esophageal mucosectomy with the olympus emr kit, the rubber of the cap ruptured and the cap fell into the patient¿s oropharynx.The cap was recovered from the patient oropharynx with forceps and the case was postponed.There was no patient harm due to the event.
Additional Manufacturer Narrative
The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the distal attachment was separated into a cap and hood, but not ruptured.The connection on the cap side had marks of manufacturer's adhesive agent applied throughout.Although the cap and hood were generally dirty, there were no abnormalities observed in the returned product.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, since there were no device abnormalities noted, the root cause of the reported event could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿use this instrument and a-cord only in combination with products recommended by olympus.If combined with products not recommended by olympus, patient injury caused by increase in patient leakage current, operator injury, malfunction or equipment damage may result.¿ this supplemental report includes a correction to d4 and d9 to provide information that was inadvertently not included in the initial medwatch.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE EMR KIT
• Common Device Name: DISPOSABLE EMR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16301818
• Report Number: 9614641-2023-00160
• Device Sequence Number: 20569584
• Product Code: FDS
• UDI-Device Identifier: 04953170048562
• UDI-Public: 04953170048562
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: K-001
• Device Lot Number: 17I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/08/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown