MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number HX-201UR-135L-A

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned for evaluation.The exact cause of the reported event cannot be determined.Based on the past similar cases, it is assumed that the event occurred due to either of the following possible causes: the sliding resistance increased between the operation wire and the coil sheath due to the shape of insertion portion or angulation of the endoscope, or the clipping was not completed since the slider was not pulled to the end.The instruction manual of the device states: "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 punctures, hemorrhages or mucous membrane damage.Do not withdraw the instrument or change the angulation of the endoscope when clipping is not completely finished (when the slider is not pulled to the end).Doing so may tear tissue inside the body cavity, resulting in patient injury, such as punctures, hemorrhages or mucous membrane damage." if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that when the rn tried to open the clip while it was inside the patient, it did not open properly and it was lost.No additional information is available regarding the event.This is report 9 of 12.

Manufacturer Narrative

This supplemental report is being submitted to provide the result of the device evaluation.The device was returned for evaluation.The returned hx-201ur-135l long quick clips (lot#85v) were evaluated due to the reported ¿¿clip did not open properly¿ issue.The returned devices were 2 used clips.In addition, 10 new, unused hx-201ur-135l long quick clips, lot #85v, were received in their original package.Visual inspection was performed on the received condition on 2 used and 3 new devices.There were no issues found with the quick clips.A functional test was performed by manipulating the clips and deploying the new devices.The test performed confirmed that the clips functioned normally.In addition, the distal end of the 2 used clips were checked and it was determined that the clips were deployed.The insertion portion was inspected and found no signs of kinks or any external damages.The slider was manipulated and the movement is consistent and smooth.The tube joint (yellow) was checked with no physical damage noted.In summary, based on the evaluation, the reported problem was not confirmed.The quick clips performed as expected and nothing unusual was noted.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Type of Device: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood ave; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8881311
• MDR Text Key: 207549218
• Report Number: 8010047-2019-02930
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-201UR-135L-A
• Device Lot Number: 85V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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