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

Model Number NM-610U-0425

Device Problems Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2020

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 224635462
• Report Number: 8010047-2020-03683
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170378058
• UDI-Public: 04953170378058
• Combination Product (y/n): N
• PMA/PMN Number: K153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 11/07/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1