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

Model Number	HX-110LR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use inspection of the hx-110lr, the operation wire of the clip device could not be projected (stuck), when the inside of the coil sheath was checked, it was found that something like metal or plastic was clogged inside the coil sheath.No patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device was received and evaluated.Evaluation found no deformation or buckling in the insertion part of the rotating clip device.There was no deformation at the tip of the insertion part of the rotating clip device.Visual check found the clip was attached to the tip of the hook.Functional test was performed for both clip and hook (pulling out and pulling in ) and was able to stick out and pull in smoothly.There were no abnormalities such as buckling of the operation wire, bending or deformation of the hook.There were no other abnormalities found that could lead to the event reported.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.D4 and h4 of the initial medwatch are updated.Correction to g3 of the initial medwatch.The aware date should be 14-mar-2022.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the clip attached to the hook caught the coil sheath and made it difficult to operate.However, the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14076185
• Report Number: 8010047-2022-06069
• Device Sequence Number: 16786943
• Product Code: MND
• UDI-Device Identifier: 04953170200182
• UDI-Public: 04953170200182
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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-110LR
• Device Lot Number: 9ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown