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

Model Number HX-610-090L

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

There are two failed devices associated with this event.These devices are captured in medwatches with patient identifiers (b)(6).This medwatch is for the patient identifier (b)(6).Due diligence is being performed for this event.Additional information is not yet available.The device is discarded by the customer and will be not returned; as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

As reported for this event by the customer, during a therapeutic procedure for a clinical trial, two of the devices used successively would not release from the clip fixing device when gripping the mucosa and had to be removed by using force.The procedure was completed by using another similar device.There is no harm or adverse impact to the patient.The devices were inspected prior to use with no anomaly noted.After looking into the matter, it was determined that the issue was with the clip and not the clip fixing device.The clip fixing device was new and a clipping test with the device of the same model number had been successful.

Manufacturer Narrative

The device has been discarded the event has been evaluated based on historical data.Additional information has been received from customer.This supplemental report is being submitted to provide this information.Patient details, including pre-existing medical conditions are not known.The model and serial numbers of the devices used in conjunction with the device at the time of the event is not known.The subject device was manufactured on september 2022 based on the provided 3 digit lot information.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on past investigations, it is likely the clip device did not release from the main unit (hx-110qr the clip fixing device) as below: clipping when the shape and angle of the scope were strict.Due to the strict shape, the sliding resistance between the operation wire and the coil sheath increased.Due to the increased sliding resistance, the force was not transmitted to the tip side, and the slider could not be pulled until the connecting rod broke.The clip could not be released because the connecting rod did not break.The instructions for use includes the following statements that warn against the issue: do not pull out the rotary clip device until it hits the slider of this product and clipping is not completed.It may lead to perforation, major bleeding, mucous membrane damage, etc.Do not pull the slider of this product until it hits the end, and do not operate the angle of the endoscope before clipping is completed.It may lead to perforation, major bleeding, mucous membrane damage, etc.If the clip does not come off from the rotating clip device, do not forcibly pull out the sheath.It may lead to perforation, major bleeding, mucous membrane damage, etc.Do not press the clip too much against the desired tissue.The intended performance may not be achieved, such as the clip being deformed and not closing completely.

Event Description

Addendum mar 7, 2023: the event occurred during hemostasis.There was no tissue injury due to the forcible removal of the clip device.There is no information if the forcible removal of the clip device led to any bleeding.There was no damage to the clip fixing device due to the forcible removal of the clip device.There was almost no delay in the completion of the procedure.It is not known if the patient needed more anesthesia.The device was inspected before use with no anomalies noted.

• Brand Name: LONG CLIP
• Type of Device: 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: 16466611
• MDR Text Key: 310628434
• Report Number: 9614641-2023-00292
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-610-090L
• Device Lot Number: 29K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HX-110QR.