MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 DAY TUBE SET; ARTHROSCOPE

Catalog Number	7211007
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump displayed an ¿cassette insertion/ pressure off set error¿ when using the pump tube set.The operation had not begun.There was no harm to the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the returned device and the reported incident from an analysis of the customer provided picture, which shows cassette insertion/pressure offset error message on the d25 control unit.The error message complaint has been confirmed and the root cause has been associated with a component failure.Factors that could have contributed to this reported event include; use of inadequate force while inserting the cassette.The missing component complaint could not confirmed because the device was not returned for evaluation.A review of the device history record showed there were no indications to suggest the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures.A review of the manufacturing process showed steps in the assembly of the device.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: DYONICS 25 DAY TUBE SET
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10073023
• Report Number: 1643264-2020-00243
• Device Sequence Number: 3881910
• Product Code: HRX
• UDI-Device Identifier: 03596010543608
• UDI-Public: 3596010543608
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: Health Professional
• Device Catalogue Number: 7211007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1