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

Model Number	HX-201UR-135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined at this time.However, the model hx-201ur-135 instruction manual warns users ¿do not use the instrument if the distal end of the coil sheath or clip pipe is deformed.Using an instrument in this condition may result in the clip catching on the rim of the coil sheath after clipping, which could make it impossible to remove the clip from the coil sheath.Confirm that there are no sharp protrusions, burrs or edges on the distal end of the insertion portion.Gently run your fingertips over the entire length of the insertion portion to check for any crushed areas, excessive bends, broken areas or other damage.Make sure that there are no cracks on the handle.¿.
Event or Problem Description
Olympus was informed that during a therapeutic colonoscopy procedure, a small piece of metal broke off from a third clip and fell into the patient¿s colon.It was reported that the physician deployed the first two clips successfully; however, this clip required multiple attempts.The patient's colon flushed and the device fragment was then suction out.There was no additional bleeding observed.The intended procedure was completed with the same device.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to make a correction on the procode from mnd to pkl.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Common Device Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7803927
• Report Number: 2951238-2018-00487
• Device Sequence Number: 16651551
• Product Code: PKL
• UDI-Device Identifier: 04953170193026
• UDI-Public: 04953170193026
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K013066
• 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): 03/08/2019

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-201UR-135
• Device Catalogue Number: HX-201UR-135
• Device Lot Number: 78K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1