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

Model Number HX-110QR

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Event 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 details have been requested regarding the reported issue.At this time, no additional information has been provided.

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.

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 past investigation reports, it is likely that foreign matter adhered to the operation pipe with the following mechanism for the rust on the wire inside the operation unit.(1)with repeated use, the coating of the operation wire rubbed against the parts inside the operation unit, generating shavings.(2)it was sterilized in an autoclave with chemicals used for cleaning mixed with them.(3)foreign matter adhered to the operation pipe during slider operation.(4)the movement of the slider became heavy due to foreign matter adhering to it. 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 olympus will continue to monitor field performance for this device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Type of Device: 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: 14252140
• MDR Text Key: 290466217
• Report Number: 8010047-2022-07352
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170200205
• UDI-Public: 04953170200205
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-110QR
• Device Lot Number: 12K
• 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
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1