MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number	HX-202UR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not being returned to olympus for evaluation, since the device was used on a patient and they no longer have it.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.
Event or Problem Description
The customer reported to olympus that the clip (subject device) was used past its expiration date.The product expired in june 2022.There was no report of patient or user injury due to the event.The customer requested a copy of the instruction manual for the device.Three more documented attempts were performed to obtain additional information, but no response was received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Although the lot number is unknown, a review of the device history record (dhr) was performed based on the likely 3-year expiration date for this product which is july 2019.The dhr found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the user used the product by mistake.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not use an instrument after the expiration date displayed on the sterile package.Doing so may pose an infection control risk or cause tissue irritation.¿ this supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15336424
• Report Number: 9614641-2022-00250
• Device Sequence Number: 12381600
• Product Code: PKL
• UDI-Device Identifier: 04953170385933
• UDI-Public: 04953170385933
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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-202UR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/10/2022
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown