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

Model Number	HX-202UR
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported event cannot be determined.A supplemental report will be filed if and when the product is returned and investigation has been completed.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
1 of 2.It was reported that the hx-202ur.A quick clip failed to deploy during a colonoscopy procedure.The clip failed to deploy when the user was trying to clip a polyp site.The device was inspected prior to use.No fragment of the device was inside the patient and therefore no fragment retrieval is needed.The intended procedure was completed with a different device.A polyp snare/biopsy was used.The current condition of the patient is good and no patient harm or injury was reported due to the event.The subject device was not available for evaluation.Related complaints: (b)(4).

• 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: 9297823
• Report Number: 8010047-2019-03903
• Device Sequence Number: 380735
• Product Code: PKL
• UDI-Device Identifier: 04953170345203
• UDI-Public: 04953170345203
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 11/08/2019

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-202UR
• Device Lot Number: 93K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1