MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number	NM-610U-0425
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due diligence was executed for this event.The device(s) are not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
Event or Problem Description
As reported for this event, upon delivery receipt inspection, it was observed that the outer packaging box in which were packed five boxes of the device was damaged.This in turn damaged the four out of the five boxes with the potential of compromising the sterility of the twenty devices within.When during shipment the damage was caused is not known.
Additional Manufacturer Narrative
The device has been returned and an evaluation performed for it.This supplemental report is being submitted to provide this information.Updating the lot # from unknown as a correction.The device history record review confirmed that there was no anomaly with appearance for the device lot indicated; the customer returned a total of four packaging/boxes item of nm-610u-0425 lot#9yk for evaluation of four boxes damaged during shipment.Manufacture date is not available.The user¿s complaint was confirmed.A visual inspection was performed on the received condition and observed all four product packaging boxes are damaged.The devices inside the packaging boxes were all inspected and found to be all sealed packing with no external damages on the physical device itself.Breakage of a cardboard box and cartons likely occurred by a physical load applied to a cardboard box after the device was shipped from the factory.The instructions for use includes the following statements: ·do not store the sterile package containing the instrument in places where it will become damaged, wet, or improperly sealed.Otherwise, the sterility of the instrument may be compromised and pose an infection control risk or cause tissue irritation.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10201626
• Report Number: 8010047-2020-03683
• Device Sequence Number: 11394536
• Product Code: FBK
• UDI-Device Identifier: 04953170378058
• UDI-Public: 04953170378058
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: No Information
• Device Model Number: NM-610U-0425
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 11/07/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1