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

Model Number	7211005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fluid leaked from the cassette and the control unit powered off and after displayed an error message.Procedure had to be completed by gravity inflow without using the control unit.The procedure was successfully completed without patient injuries or complications.After the event, it was confirmed that the transducer membranes was missing.
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.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.

• 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 6512
• MDR Report Key: 7148424
• Report Number: 1643264-2017-01857
• Device Sequence Number: 1173988
• Product Code: HRX
• UDI-Device Identifier: 03596010543578
• UDI-Public: (01)03596010543578(17)200731(10)50675033
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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 Expiration Date: 07/31/2020
• Device Model Number: 7211005
• Device Catalogue Number: 7211005
• Device Lot Number: 50675033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1