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

Model Number	K-002
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during endoscopy, when inserting the mucosectomy kit, the cap split in two.The detached part got stuck in the esophageal mouth, and the piece was recovered with difficulty using rat's tooth forceps.The procedure was completed using another endoscope without reports of further patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction to b1.B1 should be marked as product problem in addition to adverse event.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: d4, d8, h3, h6, h11.The device was returned to olympus and the reported failure was confirmed.The device inspection found distal attachment split in two parts.One part was significantly discolored.A root cause could not be identified.Based on the investigation findings, the likely cause of the malfunction was forceful insertion of the instrument despite resistance.It is recommended to reduce endoscope angulation until the instrument advances smoothly.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21980548
• Report Number: 9614641-2025-00679
• Device Sequence Number: 13035444
• Product Code: FDS
• UDI-Device Identifier: 04953170048579
• UDI-Public: 04953170048579
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: K-002
• Device Lot Number: 45K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 06/27/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/16/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown