MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that during a diagnostic colonoscopy procedure single use repositionable clips were deployed to achieve hemostasis and the clips reopened.Reportedly, clips did not stay attached to the bleeding spot in the patient and no parts fell inside the patient.Hemostasis was achieved after attempting to complete the procedure with 2 clips.The procedure was delayed for approximately 15 minutes.No additional intervention was performed.Patient identifier - (b)(6).This is report 1 of 2.Please see report with related patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.The subject device was manufactured in july 2022, but the specific date 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, it is likely the phenomenon of the "extension of procedure time (bleeding state)" was due to the occurrence of the device malfunction.However, the root cause of the phenomenon could not be determined.Additionally, the phenomenon of "clip opened and snapped into place, but clip stuck in tube and never released" it is likely that the trigger effect was not obtained due to the following mechanism: 1.The slider was pulled for the clipping.2.Due to the following compounded factors, a force of pulling the slider was reduced before it reached to the clip.Resistance between the operation wire and the coil sheath increased due to the shape of the scope or excessive angle of the scope.The amount of force required to close the clip increased due to the large amount of grasping object.Hard tissues were grasped.The base of the arm was pressed against the tissue, making it difficult to close the clip.3.A force required to close the clip did not be reach to the clip.Therefore, the limiter located in the slider broke (heard the snapping sound) before the clip completely closes.4.Since the limiter made a snapping noise, the user pulled the slider as he/she was misunderstanding that the clipping was completed.5.Since the clip was not closed completely, it could not be released.(the clip arms were being opened.) the root cause of the phenomenon could not be determined.The event can be prevented by following the instructions for use which state: "1.When pulling the slider, the operation wire, the hook and the clip arms are linked together, and they are pulled together in the proximal direction.This motion closes the clip arms.2.When the slider is further pulled after closing the clip arms, the protrusions of the clip arms will move to the outside of the clip pipe.Once it happens, the small protrusions of the clip arms will be fix to the edge of the clip pipe.As a result, the clip cannot be opened or closed.(see fig.4) the clip can be opened and closed by operating the slider to a position where the small protrusions of the clip arms do not come out of the clip pipe.3.When the slider is further pulled after the clip does not open or close, the limiter located in the slider breaks with the noise of snapping.(the user recognizes that clipping was completed by hearing the sound.) 4.After the limiter breaks, the joint between the hook and the clip arms will be unhooked by moving the slider forward.As a result, the clip will be released from the product.(see fig.5)." "when the bending section of the endoscope is excessive angulation and/or the target tissue is firm, the pulling force acted on the control section may not convey to the clip adequately, making clipping unsuccessful.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip cannot be detached from the instrument or if any other unexpected circumstance takes place.In this case, refer to chapter 14, ¿emergency treatment¿.Do not withdraw the instrument forcibly or change the angulation of the endoscope when the clip is grasping the tissue and is not released.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.Do not angulate the bending section of the endoscope or withdraw the instrument from the endoscope while the clip is grasping the tissue before being released.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.Do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding, or mucous membrane damage.Should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of ¿withdrawing the instrument from the endoscope¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result.Do not force the clip against body cavity tissue.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.The clip may be deformed and therefore does not close properly.This could result in reduced performance.Keep the insertion portion of the instrument that extends from the biopsy valve and the insertion portion of the endoscope as straight as possible.Do not perform clipping with the insertion section being coiled.Otherwise, the force exerted on the control section may not convey to the clip adequately during clipping.This could result in reduced performance, making it impossible to close the clip or detach it from the coil sheath after clipping." olympus will continue to monitor field performance for this device.

Event Description

The customer confirmed that no device fell into the patient and the clip stayed in the tube.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL 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: 16962523
• MDR Text Key: 315758733
• Report Number: 9614641-2023-00699
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 27K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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-202UR