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

Model Number HX-202UR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported by the customer, during an unspecified therapeutic procedure using single use repositionable clips, after the clip was applied, the clip failed to release.A second clip was used and failed as well.Excessive force was used to attempt to release the clips, the patient experienced a tissue tear as a result of these events.The tear was managed with a clip (brand and model number not provided), and the procedure was completed.Case with patient identifier (b)(6) reports the first clip that failed.Case with patient identifier (b)(6) reports the second clip that failed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Repeated attempts were made to obtain the device for further testing and evaluation as well as requests for additional information however, those request were unsuccessful.Because the device was not returned and based on the results of the investigation, a root cause could not be determined however, the phenomena likely occurred due to the following scenarios.It is likely that the clip did not detach due to the following reason: 1.Slider not fully pulled back the endoscope was angulated.Therefore, resistance was felt when moving the slider, or the slider was not fully pulled until it reached to the slider.As a result, the clip could not be released.2.Damage of the limiter the sliding resistance inside the clipping device increased when the insertion portion of the endoscope was looped or excessively angulated.Clipping was performed under the circumstances described above.This caused the limiter to break before the clip and the clip pipe were locked.Therefore, clipping was not possible.3.The endoscope or subject device was pulled while the clip was grasping the tissue.The endoscope or the subject device was pulled while the clip was still grasping the tissue.This applied a tensile force to the connecting area between the hook and the clip.As a result, the clip could not be released.4.The slider was not pushed.The slider was not pushed forward to release the clip.It is likely that the tissue was torn by the following mechanism: 1)the clip was not separated from the sheath.2)the device was pulled due to handling such as withdrawing the instrument forcibly or changing the angulation of the endoscope.3)the clipped tissue was pulled by handling of 2).As a result, the tissue was torn.The following is included in the device 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, ¿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¿.Otherwise, perforation, bleeding, or mucous membrane damage may result." "push the slider until the clip is detached from the coil sheath " 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: 12557819
• MDR Text Key: 274298523
• Report Number: 8010047-2021-12523
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: HX-202UR
• Device Lot Number: 05K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Other