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 Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference device was not returned to the service center for a physical evaluation.However, a photo image of the device was received and the investigation is currently in progress.The exact cause of the reported event cannot be determined at this time.The service center followed up to obtain additional information regarding the reported event but with no result.The instruction manual warns users ¿before use, prepare, and inspect the instrument as instructed.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.
Event or Problem Description
Service center was informed that during a procedure the quickclip "exploded" (broke apart) inside the patient.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the result of the investigation and to update section h6.The suspect device was not returned for evaluation.Based on similar reported complaints, the oem determined the problem is a previously identified failure, previously investigated.Based on the investigation of similar reported complaints, the oem has determined that the affected clips conform to olympus product specification standards and the incident rate is within acceptable range.

• 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: 8875005
• Report Number: 8010047-2019-02906
• Device Sequence Number: 14087425
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 93K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1