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	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the service center for evaluation for the reported event; therefore, the exact cause cannot be determined.Upon receipt of the device, an evaluation will be performed and a supplemental report will be submitted.The instruction manual contains several statements to prevent damage to the device and are as follows: "when inserting the instrument in to the endoscope, hold it close to the biopsy valve and keep it straight as possible relative to the biopsy valve.Otherwise, the insertion portion, could be damaged.Do not insert the instrument into the endoscope if the clip is not completely retracted into the sheath it could cause patient injury such as perforation, bleeding, or mucous membrane damage may result.It could also damage the endoscope, instrument, and/or clip.Do not advance or extend the instrument abruptly.This could also cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope, instrument, and/or clip.".
Event or Problem Description
The service center received a report of a quick clip pro (hx-202ur) that broke off into a scope during an unspecified procedure.It was not reported if the repositionable clip was retrieved or if the intended procedure was completed.It was reported there was no patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information provided by the reporting facility.Please see updated sections: b5, g4, g7 h2, and h10.
Event or Problem Description
The service center received a report of a single use repositionable clip (hx-202ur) that fell off/early deployment during a colonoscopy procedure.It was originally reported that the clip, hx-202ur, broke off into the scope, but upon additional information from the reporting facility, it was learned that the clip deployed prematurely while the physician was advancing the device in the scope.The clip deployed early when the physician was inserting the clip in the scope and was advancing it, the device stopped.The physician removed the device and observed the clip had fallen off the end of the device.Upon retrieval, the physician observed the clip, hx-202ur, was still in the scope and had not fallen into the patient.The clip was safely retrieved back out of the scope.It was reported there was no blood loss, no patient injury.It is unknown if the intended procedure was completed.

• 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: 9527459
• Report Number: 8010047-2019-04665
• Device Sequence Number: 18932239
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/07/2020

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: 91K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1