MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LONG CLIP

Model Number	HX-610-090L
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a hemostasis clip was suctioned within the patient¿s stomach and caused suction issues during a diagnostic endoscopic procedure and the customer suspects the clip may have remained within the gastrointestinal videoscope after a previous procedure and it was not reprocessed correctly.The clip was suctioned and removed during the procedure.There was no report of patient injury or medical intervention associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The manufacturing date cannot be identified because the serial/lot number is unknown.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, and since the device was not returned for evaluation due to the facility discarding it, the definitive root cause of the reported issue could not be determined.The event can be detected/prevented by following the instructions for use (ifu) (drawing number:gk4802, revision number : 27): when aspirating body fluid via the endoscope, be careful not to aspirate a clip or clip connector which has been dropped inside the body cavity, as this could clog up the suction channel or cause the clip/clip connector to be stuck in the suction valve and disable the endoscope¿s suction function.If a clip or clip connector is accidentally aspirated into the endoscope, follow the procedure given in ¿removal of an aspirated clip or clip connector¿ on page 35.Removal of an aspirated clip or clip connector, if a clip or clip connector is accidentally aspirated into the endoscope, follow the procedure below to remove it: withdraw the endoscope from the body cavity, keeping the insertion portion and bending section straight.Leave the biopsy valve mounted on the endoscope.Remove the suction tube and connect a syringe filled with tap water to the endoscope¿s suction connector.While gently pressing the suction valve, inject the tap water into the endoscope¿s suction connector.Olympus will continue to monitor field performance for this device.

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• 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: 20061166
• Report Number: 9614641-2024-01709
• Device Sequence Number: 7784900
• Product Code: PKL
• UDI-Device Identifier: 04953170415159
• UDI-Public: 04953170415159
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240617
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: HX-610-090L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 08/25/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H290T- GASTROINTESTINAL VIDEOSCOPE
• Patient Sex: Unknown