MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Mechanical Problem (1384)

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

Event Date 02/09/2022

Event Type  malfunction  

Event Description

The customer reported that during an endoscopic submucosal dissection, there were three single use repositionable clips that did not release from the applicator after deployment.The procedure was completed using a similar device.There was no clinically relevant prolongation of the procedure, and no patient injury was due to the event.The first clip is being submitted under medwatch with patient identifier (b)(6) (this report).The second clip is being submitted under medwatch with patient identifier (b)(6).The third clip is being submitted under medwatch with patient identifier (b)(6).

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is in process.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 10-feb-2022.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The subject device was returned and evaluated where it was found that the clip was released from the product, the clip was inside a tube, operability of the slider presented no abnormalities, appearance of the hook presented no abnormalities, and the limiter placed inside the control section of the clipping device was broken.Before providing the root cause, the following information regarding the steps to release the clip will be provided.This information helps to understand the content of the root cause of the reported event.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.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.Based on the result of confirming the subject device, the clip was released in the tube.Therefore, a likely factor causing the clip not to be able to detach from the device might be the following: 1) the clip pipe was covered with the tube sheath when clipping was performed.2) under the condition #1), the slider was pushed to extend the hook from the coil sheath for releasing the clip.3) as the connecting area between the hook and the clip was covered with the tube sheath, the clip does not easily come off hook.The following is including in the device instructions for use (ifu) and may help prevent and/or detect the reported issue: "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." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see h6 for further detail.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13934510
• MDR Text Key: 295262876
• Report Number: 8010047-2022-05166
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170345180
• UDI-Public: 04953170345180
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 13K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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