MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RELOADABLE CLIP APPLICATOR

Model Number	HX-810UR
Medical Device Problem Code	Use of Device Problem (1670)
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
As reported, " when a sales representative visited the facility, the disposable product was eog (ethylene oxide gas) sterilized and reused.Currently, no health hazards have been reported to patients.According to reporter, the usage period is less than one month (used it repeatedly about 3 to 4 times).There was no patient harm or injury reported.No user injury reported.
Additional Manufacturer Narrative
The subject device was not returned to the sbc (service business center ) olympus.Supplemental report(s) will be submitted should any relevant new information is available and or received.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.Based on the results of the investigation, there is no problem due to an abnormality or deficiency in the product.The olympus representative explained to the facility in advance that the device is a disposable product.The instruction manual states that this product is a disposable product, and that reuse is prohibited.The subject device was not returned to olympus.Therefore, the reported phenomenon and condition of the device could not be confirmed.The lot was not provided, and the manufacture date cannot be identified.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Additionally, the dhr for over the past year prior to the event date was inspected.No abnormalities found in the dhr of the following items which relate to the reported phenomenon.1.Process inspection sheet; 2.Quality inspection sheet; 3.Nonconforming product report.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: ¿the clip applicator and clip are single use, disposable items.Do not reuse or attempt to sterilize them.Reusing the clip applicator or clip could pose an infection control risk, tissue irritation, or malfunction.After use, dispose of the clip applicator and clip in an appropriate manner.If they are not properly disposed of, they could pose an infection control risk.The clip applicator and clip are single use, disposable items.Do not reuse or attempt to sterilize them.Reusing the clip applicator and clip could pose an infection control risk, tissue irritation, or malfunction.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RELOADABLE CLIP APPLICATOR
• Common Device Name: CLIP APPLICATOR
• 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: 14623406
• Report Number: 8010047-2022-09570
• Device Sequence Number: 4391034
• Product Code: PKL
• UDI-Device Identifier: 04953170421341
• UDI-Public: 04953170421341
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183590
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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-810UR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown