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  

Event Description

When the clip was inside of the patient and the rn tried to open the clip and it did not open properly and it was lost.Updated: changed pae answer from n/n to n/y, and escalated the aedt to mq analyst.Mbh 16jul2019.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation and to correct section d10.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
• MDR Report Key: 8881455
• MDR Text Key: 213243518
• Report Number: 8010047-2019-02926
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1