MAUDE Adverse Event Report: GYRUS ACMI, INC. COLLECTION SET TUBING PVC (10/PK)

Model Number	23116
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the collection set tubing package had a hair in it.It is unknown when the issue occurred.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the results of the device evaluation, the legal manufacturer's final investigation, and information received from the customer.Additional information added to the following fields: b5, d9, e2, e3, g2 (added selection), h3, h4, h6 the device was returned to olympus unopened and in its original packaging.Upon inspection, a singular half inch piece of hair was found inside.The customer's reported issue was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than a year since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was provided.The debris in the package was found during preparation for use and it was discovered prior to opening the package.

• Brand Name: COLLECTION SET TUBING PVC (10/PK)
• Common Device Name: COLLECTION SET TUBING PVC (10/PK)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20077401
• Report Number: 3011050570-2024-00346
• Device Sequence Number: 6424068
• Product Code: HHI
• UDI-Device Identifier: 00821925030954
• UDI-Public: 00821925030954
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K030935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 23116
• Device Lot Number: S240100636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown