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

Model Number	60-7070-157
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, the complaint device showed no signs of clinical use.The device was found to be non-hermetic.Air was found leaking at one tube where it enters the molded joint.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: - ptc damaged or broken during use (leak).The instructions for use (ifu) state: -warnings: --it is important that the tourniquet cuff be applied at the proper location with adequate pressure for the appropriate amount of time.--avoid needles, towel clips, leg holders and other equipment that can puncture or otherwise damage the cuff.-directions for use: --before beginning the procedure, verify compatibility of all devices and accessories.--prior to surgery, select the proper sized tourniquet cuff by measuring the circumference of the patient's limb.This will avoid problems caused by a tourniquet cuff that is too small or too large.-to prevent intraoperative bleeding, avoid the following: under pressurizing the cuff, insufficient exsanguination, excessively slow inflation and deflation, poor tourniquet pressure" --secure the cuff fasteners to ensure that the cuff stays in place during the procedure.--if the package is damaged or if it was opened and the device was not used, return the device and packaging to stryker sustainability solutions.--inspect the device for overall condition and physical integrity.Do not use the device if any damage is noted.Return the device and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the tourniquet was leaking where the tubing connects.The device was at the proper level of pressure and they continued the case with the device.There was no patient injury, medical intervention, and extended procedure time reported was unknown by the customer.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Upon further investigation, the most likely root causes of the reported event have been attributed to: ptc damaged or broken during use (leak); inadequate leak testing on device.
Event or Problem Description
It was reported the tourniquet was leaking where the tubing connects.The device was at the proper level of pressure and they continued the case with the device.There was no patient injury, medical intervention, and extended procedure time reported was unknown by the customer.These are commonly used devices that are readily available.

• 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: 6389947
• Report Number: 0001056128-2017-00047
• Device Sequence Number: 942947
• Product Code: KCY
• UDI-Device Identifier: 00885825017675
• UDI-Public: (01)00885825017675(17)170730(10)3851205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 07/30/2017
• Device Model Number: 60-7070-157
• Device Catalogue Number: 60-7070-157RR
• Device Lot Number: 3851205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1