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

Model Number HX-202UR

Device Problem Failure to Discharge (1169)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus but has not yet been evaluated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, upon initial use, the single use repositionable clip would not deploy.It was reported that the clip opened and closed, but would not deploy.The issue was found during a colonoscopy procedure.The clip did not fall into the patient.The procedure was not prolonged.It took ten seconds to replace the clip with a cook medical clip.The clip was not forcibly removed, it was removed according to the instructional manual.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to h6.The limiter in the control section of the clipping device was broken off.The dimensions of the hook was measured and found to be within specifications.Limiter dimensions were within specifications.Olympus will continue to monitor field performance for this device.

Event Description

Additional information was received from the customer which confirmed the endoscope used for the procedure was cf-h190al.The angle of the endoscope was straight during use and when inserted into the body.The shape of the endoscope was normal straight colon and it was in the descending colon when the deployment failed.The insertion portion was straight when it protruded from the biopsy valve.The clipping was performed in the descending colon.The tissue was clean cut, thick predunculated polyp when the clipping was performed.Additionally, the mucosa was thick but was a predunculated polyp.The tissue was stiff and firm.The clip was not forcefully pressed when the physician clipped the stalk.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation, and correction to g2.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.A visual inspection was completed on the single user repositionable clip.During inspection it was found that the clip was still attached to the distal end.There was no signs of crushed areas, excessive bends, broken areas, or damages.The slider movement on the handle, that opens and detaches the clips, is normal.Also, functional inspection was performed, and it was observed that the clip was unable to detach and it was still dangling on the j hook, even after the slider was forcibly pulled with both hands.However, the closed clip was reopened when the slider was pushed.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 root cause of the clip not deploying was unable to be identified.However probable causes of this event include: the slider was pulled for the clipping.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.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.Since the limiter made a snapping noise, the user pulled the slider as he/she was misunderstanding that the clipping was completed.Since the clip was not closed completely, it could not be released.(the clip arms were being opened.) 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 (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: 16709678
• MDR Text Key: 313014390
• Report Number: 9614641-2023-00481
• 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,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 27K 19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 08/31/2023
• Supplement Dates FDA Received: 06/07/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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