MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; TOURNIQUET, PNEUMATIC

Model Number	60-7070-105
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for an evaluation.A review of the device history record indicates the device met all inspection and test criteria prior to release.During functional testing, the device was found to be non-hermetic, leaking at a rate of more than 1.0 l/min.The most likely root cause was determined to be excessive pulling/twisting on the tubing during use.The instructions for use (ifu) states: "avoid needles, towel clips, leg holders and other equipment that can puncture or otherwise damage the cuff." "it is important that the tourniquet cuff be applied at the proper location with adequate pressure for the appropriate amount of time." the reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the device leaked during the procedure.There was no patient injury, medical intervention, and extended procedure time reported was minimal.

• Brand Name: NA
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6028873
• Report Number: 0001056128-2016-00136
• Device Sequence Number: 75606
• Product Code: KCY
• UDI-Device Identifier: 00885825013868
• UDI-Public: 00885825013868
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2016

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: 07/15/2018
• Device Model Number: 60-7070-105
• Device Catalogue Number: 60-7070-105RR
• Device Lot Number: 4745288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1