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

Model Number HX-202UR

Device Problems Failure to Form Staple (2579); Detachment of Device or Device Component (2907)

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

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

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.This report was submitted by the importer under the importer's report number: 2429304 - 2023 - 00041.

Event Description

A user facility reported to olympus that while using a single use repositionable clip during a colonoscopy with polypectomy, the clip would seal and fire but would not stay closed once deployed after the surgeon pulled it from the mucosa.The clip did fall into the patient, and was retrieved.A different device and four clips were used to complete the procedure.The procedure was delayed while the circulating nurse retrieved another device.There was no patient injury.Three clips in total were returned but it was unknown if all three were used in the procedure.Additional information was requested multiple times without response.Patient identifier (b)(6) is for clip with lot number 27k 20.Patient identifier (b)(6) is for clip with lot number 27k 15.Patient identifier (b)(6) is for clip with lot number 275 15.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Visual inspection as received condition found clip open and still attached on the distal end.The handle was operational as it could open, and close the clip as intended.No damages were found on the handle or the coil sheath.Functional inspection was performed, and olympus observed the clip would not detach and still dangling on the hook, even after the slider was forcibly pulled with both hands.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus confirmed "deploy prematurely" is reproduced when the clip arm is opened and closed using a method not recommended/included in the instructions for use (performed on lot 24k - 2yk and reproduced at 24k).In addition, the dimensions of the available lots (24k to 2yk) were checked to see if the occurrence of this phenomenon was caused by the dimensions of the parts.The dimensions of the hooks and clip arm related to this phenomenon were within the standard values.However, "deploy prematurely" is more likely to occur when clearances are smaller.The clearance plays a significant role to open and close the clip arm.Size of the clearance affects detachment of the clip arm and operability such as ¿ deploy prematurely¿.Detachment of the clip arm easily occurs when the clearance becomes larger.On the other hand, ¿deploy prematurely¿ easily occurs when the clearance becomes smaller.The clearance of the measured products fell within the standard values.However, it was confirmed that the size of clearance was close to the lower limit.When the clearance is small, the clip arm will be placed in a specific position against the hook.When the incorrect steps are followed, such as closing the clip arm in the tube sheath, or opening and closing the clip arm repeatedly by not grasping anything in the clip arm, causing the clip pipe to get stuck at the rear end.This possibly leads to "deploy prematurely".Based on the results of the investigation, an association between adverse events and the device could not be ruled out.It is likely the event occurred when the clip could not be reopened because the "deploy prematurely" occurred.It is also possible that the limiter was ruptured and could no longer be released.Based on the results of the present product confirmation and the results of the reproduction study to date, it is considered 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.) as for "deploy prematurely" there were no problems in the investigation, and no abnormalities were found in the product.The event can be detected and prevented by following the instructions for use which state: ¿"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: LIGATION CLIP, METALLIC
• 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: 16525998
• MDR Text Key: 311127859
• Report Number: 9614641-2023-00364
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 27K 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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: SINGLE USE REPOSITIONABLE CLIP - LOT 27K 15.; SINGLE USE REPOSITIONABLE CLIP - LOT 27K 15.
• Patient Outcome(s): Required Intervention