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

Model Number HX-202UR

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

Customer reported three events of the device being difficult to release during procedure upon regular use of the device.Procedure was therapeutic polypectomy or mucosectomy.The procedure was completed with the same device.Normal time to release the device is five minutes.Ten additional minutes were required due to this event.There is no harm or adverse impact to the patient.This type of device was used in other procedures subsequently.Opinion of the physician is that there could have been risk of perforation of the patient making the situation dangerous.

Manufacturer Narrative

Customer reported three events of failed devices.These events are captured in medwatches with patient identifiers (b)(6).This medwatch is for the patient identifier (b)(6).Customer has reported this event to the french national agency for the safety of medicines and health products (ansm).Customer who reported to ansm that, customer is not aware if this type of incident is provided for in the instructions for use.Customer will change manufacturer.Customer has kept the device quarantined but note returned the device as yet; as such, a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The evaluation was completed.During device evaluation, the phenomenon was not reproduced.As there are no abnormalities as well as in appearance, we could not determine the cause of the phenomenon based on the investigation result.The clip was attached to the device when it arrived for investigation, no buckling was observed in the insertion portion, and there were no problems with slider operability.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.It is possible that the slider was not fully pulled until the limiter placed in the control section broke.Therefore, the clip could not be released from the product.However, the exact cause could not be determined.The following information is stated in the instructions for use (ifu): ¿·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¿.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.·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.

• 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: 16224375
• MDR Text Key: 307908494
• Report Number: 9614641-2023-00101
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: HX-202UR
• Device Lot Number: 12K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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