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

Model Number	HX-202UR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned as the user facility discarded the device during procedure.Therefore, the exact cause of the reported event remains unknown.As a preventive measure, the instruction manual provides warning which indicates, do not insert the instrument into the endoscope if the clip is not completely retracted into the tube sheath.If the clip is not retracted, move the tube joint (yellow) in the distal direction until the clip is retracted into the tube sheath, then insert the instrument into the endoscope.Otherwise, patient injury, such as perforation, bleeding, or mucous membrane damage may result.It could also damage the endoscope, instrument, and/or clip.
Event or Problem Description
The manufacturer was informed that during a colonoscopy with polypectomy procedure, the device reportedly misfired and multiple pieces of the clip broke off and fell inside the patient's colon.The doctor retrieved most of the broken clip fragments, however, there was one piece of the clip that was not retrieved.The facility did not seem too concerned as they stated they leave clips in the colon all the time and that the piece of the clip will pass through the patient naturally.The technician immediately discarded the device and opened another that deployed without incident.The charge nurse indicated the technician was not as familiar with the clips and noticed the technician did not advance the clip to the end of the sheath when handing it to the physician.However, it was unknown if it was a faulty clip or the technician's handling.

• 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: 9156264
• Report Number: 8010047-2019-03498
• Device Sequence Number: 13994398
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: 95K
• 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: 09/06/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1