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

Model Number	7211007
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the pressure was set on "30" but an overpressure happened resulting in edema.The water jet was even outside of the knee.The procedure was interrupted.No patient injury reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection was performed on the product and there were no issues found with unit.The unit was tested at various pressure settings (30, 50, 80, 100, and 150 inhg) for a total of 50 mins, two pressure transducer were used to measure the pressure that the unit was maintaining.The unit was able to maintain the set pressure with a range of -1 to -4 inhg.At a set point 30 inhg the unit was maintaining a pressure of 29 inhg and 28 inhg at the 2 transducers.Overpressurization was not observed during the functional testing.A dimensional analysis was performed on the diameter of the outflow tubing and the cassette orifice, both dimensions were within tolerance.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the functional testing process.Factors which could have contributed to the reported event include a defective transducer on the concomitant device or crimped inflow tubing.

• Brand Name: DYONICS 25 DAY TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK
• MDR Report Key: 7587422
• Report Number: 1643264-2018-00442
• Device Sequence Number: 18883220
• Product Code: HRX
• UDI-Device Identifier: 03596010543608
• UDI-Public: (01)03596010543608(17)201231(10)50700814
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 12/31/2020
• Device Model Number: 7211007
• Device Catalogue Number: 7211007
• Device Lot Number: 50700814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 10/28/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1