MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number	MAJ-891
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the forceps/irrigation plug was incorrectly reprocessed.The facility was interviewed by the olympus representatives and stated deviation from the reprocessing guidelines.The issue occurred during an unknown event and procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: (b)(6).Added here due to character limitation in respective field.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus for inspection as it was being inspected onsite.The event of the customer not reprocessing according to the instructions for use (ifu) was not reproducible, therefore, could not be confirmed.Based on the results of the investigation, it was presumed that there was a difference in recognition on item handling or reprocessing steps between olympus recommendation and the user.The root cause could not be specified.The events can be detected and prevented in accordance with the following sections of the instructions for use (ifu): an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ to warn about inappropriate reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Common Device Name: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20433512
• Report Number: 9610595-2024-20811
• Device Sequence Number: 20730335
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: MAJ-891
• Was Device Available for Evaluation?: No
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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