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

Model Number	HX-610-090SC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a procedure for marking purposes, when the colored short clip was loaded and the clip bullet was removed from the sheath inside the body, the clip fell off.The fallen pieces (metal part and clip case) were collected.The procedure was completed after replacing the device.There was no reported patient impact.
Additional Manufacturer Narrative
E1/establishment name: (b)(6) hospital added here due to character limitation in respective field.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (d9), and to provide an update to fields (h3 and h4).The device was evaluated by olympus, and no reportable malfunctions were found that could have led to the reported event.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, it is likely the reported event occurred due to the hook of the rotary clip device was pushed out too far, causing it to strike the tissue inside the body.However, a specific root cause could not be identified.The event can be detected/prevented by following the instructions for use which state: "do not extend the clip abruptly from the distal end of the coil sheath.Also, when pushing the clip out of the coil sheath, keep a sufficient distance between the distal end of the coil sheath and the mucous membrane.If the clip is extended without keeping this distance, the clip may hit against the tissue unintentionally, and perforation, hemorrhage or mucous membrane damage or dropping off of the clip, or break up of the clip may result." "do not force the clip against body cavity tissue.The clip may be deformed and does not close properly.This could result in reduced performance." olympus will continue to monitor field performance for this device.

• Brand Name: COLORED SHORT CLIP
• Common Device Name: COLORED SHORT 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: 20314248
• Report Number: 9614641-2024-01884
• Device Sequence Number: 15356944
• Product Code: PKL
• UDI-Device Identifier: 04953170200397
• UDI-Public: 04953170200397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: HX-610-090SC
• Device Lot Number: 3ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown