MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLOW/OUTFLOW TUBE SET (3); ARTHROSCOPE

Model Number	7211005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, there was a fluid leakage from the cassette.Backup device was available to complete the procedure.No delay and no patient injuries were reported.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 returned to the designated complaint unit for independent evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection of the returned device noted the inflow to cannula tube set color is clear instead of blue.Functional evaluation of the device did not reveal any malfunction.No fluid leakage from the cassette.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: DYONICS 25 INFLOW/OUTFLOW TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10566365
• Report Number: 1643264-2020-01250
• Device Sequence Number: 3578095
• Product Code: HRX
• UDI-Device Identifier: 03596010543578
• UDI-Public: 03596010543578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/26/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 7211005
• Device Catalogue Number: 7211005
• Device Lot Number: 50840548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1