MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3); ARTHROSCOPE

Model Number	7211006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when a brand new cassette was installed into a control unit and the irrigation was started, the fluid leaked from the cassette and the control unit had a power down after displaying error message.They had to use a gravity inflow without using the control unit.No patient injuries were reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.Tube set evaluation revealed that transducer membranes were missing from the cassette.The complaint was confirmed and a root cause has been associated with a manufacturing error.

• Brand Name: DYONICS 25 INFLW/OUTFLW FORK SUCTN (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 6816058
• Report Number: 1643264-2017-00497
• Device Sequence Number: 19229802
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: (01)03596010543592(17)200131(10)50642202
• Combination Product (Y/N): N
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 7211006
• Device Catalogue Number: 7211006
• Device Lot Number: 50642202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1