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

Model Number HX-202UR

Device Problems Difficult to Remove (1528); Separation Failure (2547)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

A user facility reported to olympus that the single use repositionable clip would not detached from the applicator.It was reported that the endotherapy reported a potential out of box failure, and the device failed upon initial clinical (therapeutic) use.The customer reported that device clips that grips the patient mucous membrane could not be detached from the applicator.The physician stated that the device clip still opens even after crunching, opens and closes but did not stay on mucosa there was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.The device was returned as used with yellow tube joint being moved toward the handle boot.Visual inspection was performed and the condition found clip open and still attached on the distal end.The opening width of the clip arms met specification (measured about 11mm).There was no abnormality on the appearance as the coil sheath and the outer sheath appeared to be normal.The device handle appeared operational as its rotate, open, or close the clip as intended.However, after multiple attempts to deploy the clip with the slider forcibly pulled with both hands, the clip still would not detach from the distal end.Based on the evaluation findings, the reported complaint was confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.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, the following are probable causes for the device clip to open after crunching: 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.) however, a final root cause was unable to be identified.The following is included in the instructions for use: ¿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.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15734705
• MDR Text Key: 307108994
• Report Number: 9614641-2022-00569
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: 25K 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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