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

Model Number	HX-202UR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the service center for evaluation.Therefore, the cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed and a supplemental report will be submitted.
Event or Problem Description
A report was received by the service center that a quick clip pro (hx-202ur) failed during an unspecified procedure.It was reported when the physician unsheathed the clip, it fell apart.It is unknown if the items were retrieved from the patient.The unspecified procedure was completed with another clip and it was reported there was no patient injury.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation and correction of lot number and manufacture date.Ten new sealed repositionable clips (hx-202ur), lot number 96k 11, were received at the service center for evaluation for quick clip ¿fell apart¿ upon deployment.The user¿s complaint was not confirmed.Four out of the ten clips were evaluated.An inspection of all four repositionable clips, observed to have the yellow joint below the handle area at its proper location.It was also observed, that the clips from the distal end, open and closed as designed when the slider was manipulated.It was noted there were no restrictions on the slider movement from the handle side.A test was performed where all four clips were fired upon plain tissue paper, and all four clips securely clasped the tissue paper and showed no signs of misfire.There was no sign of external damages noted on the insertion portion of the tube sheath, clip, slider, yellow joint and handle.Based on the evaluation of the new received condition repositionable clips (hx-202ur), lot number 96k 11, evaluated; the reported event could not be determined as there were no abnormalities or damages observed with the devices.

• 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: 9490456
• Report Number: 8010047-2019-04405
• Device Sequence Number: 2086284
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: 96K 11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1