MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. LONG CLIP

Model Number	HX-610-090L
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The clip of the device was closed.The clip connector of the device was not broken off.The clip was deformed.We could not find anomalies related to the reported event.We could not find adhesion of foreign material such as tissues on the device.We tried to get additional information.However, no additional information was provided.We were able to attach the device on the hook of a rotatable clip fixing device owned by our company and detach the device from the hook when we checked the operation of clipping.The reported event was not reproduced.The exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.There is a possibility that the reported event was caused by the following.The device was deformed since the device was forced against tissues.The operating force of the handle was increased due to the deformation of the device, and the user was not able to pull the operational handle of a rotatable clip fixing device until the end.The above device handling has warned in the instruction manual as follows.Do not force the clip against body cavity tissue.The clip may be deformed and does not close properly.This could result in reduced performance.
Event or Problem Description
We received the following report.The clip failed to deploy (the clip could not be released).The user withdrew the clip with a rotatable clip fixing device from the patient.The intended procedure was completed with another device.There was no patient injury reported.

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8685861
• Report Number: 8010047-2019-02167
• Device Sequence Number: 2511171
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: No Information
• Device Model Number: HX-610-090L
• Device Lot Number: 92K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1