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

Model Number	HX-110QR
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that rust was adhered to the operation wire of the subject device and movement of the slider was difficult.This report is being submitted for the issue (foreign material on the operation wire) reported by the customer.The reported issue occurred during reprocessing of the device.The device had been reprocessed by autoclave sterilization.There was no report of patient or user harm due to the event.
Additional Manufacturer Narrative
The device has been returned to an olympus service center for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and correction to d4.D4 - corrected the lot number to 12k.The device evaluation was completed and found the lot number was 12k.There was no buckling at the insertion point.There were no abnormalities at the tip of the coil sheath such as misalignment, buckling, or deformation.The slider operation was heavy, and the metal did not feel heavy from rubbing, but rather sticky.A black-colored foreign substance was adhered to the control pipe of the actuator.The foreign matter adhered to most of the areas of the slider's operating range.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to the lot number.D4: updated with the correct lot number.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was manufactured on september, 2021 based on the provided 3 digit lot information "19k".The device was returned to olympus for inspection, and the customer's complaint was confirmed.Additionally, the repair center found -there was no buckling in the insertion part.-there were no deviations, buckling, deformation, or other abnormalities at the tip of the coil sheath.-when i checked the operation of the slider, the operation of the slider was heavy.-a blackish foreign matter was attached to the operation pipe of the operation part.-foreign matter adhered to almost the entire operating range of the slider.-as a result of material analysis, it was found that it was a mixture derived from the ptfe coating applied to the operation wire, internal parts, and chemicals such as detergents.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, there was a possibility that foreign matter adhered to the operation pipe with the following mechanism for the rust on the wire inside the operation unit.-with repeated use, the coating of the operation wire rubbed against the parts inside the operation unit, generating shavings.-it was sterilized in an autoclave with chemicals used for cleaning mixed with them.-foreign matter adhered to the operation pipe during slider operation.-the movement of the slider became heavy due to foreign matter adhering to it.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: 14252789
• Report Number: 8010047-2022-07354
• Device Sequence Number: 4736425
• Product Code: PKL
• UDI-Device Identifier: 04953170200205
• UDI-Public: 04953170200205
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2022

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-110QR
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 07/01/2022; 09/02/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/28/2022; 07/29/2022; 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown