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

Model Number	HX-202UR
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.The cause of the reported event cannot be determined.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.".
Event or Problem Description
It was reported that during an unspecified procedure, the hx-202ur clip came apart inside a patient.The clip went to open, deployed and detached from the catheter exposing the spring.The detached clip was retrieved and the intended procedure was completed using another clip.There was no patient harm or injury reported due to the event.
Additional Manufacturer Narrative
37 brand new and sealed hx-202ur.A quick clips (lot# 96k 27) were returned for evaluation.Eight of thirty-seven hx-202ur quick clips (lot 96k 27) were evaluated due to ¿clip failed to deploy correctly¿ issue.Visual inspection performed on received condition on the 8 of the 37 quick clips.Visual inspection did not find any problems.The handle was manipulated to be able to perform a deployment functional testing.The deployment testing passed with no issues observed.The insertion portion was inspected and did not find any external damages.The handle was manipulated and the movement is consistent and smooth.The yellow tube joint was checked and no damage noted.Based on the evaluation, the reported issue was not able to be confirmed as the device deployment functions operate normally with no signs of abnormalities.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9418724
• Report Number: 8010047-2019-04168
• Device Sequence Number: 2490839
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 96K27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1