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

Model Number	5921-030-135
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical opinion holds that the reported volume of blood loss of 20 cc is minor and not serious.The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, the complaint device showed signs of clinical use.There was no apparent damage to the tubing or connectors.The device was found to be non-hermetic.There was a small hole near the seam by the velcro ribbon.Air was found escaping at the hole.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).Ptc coming into contact with sharp object or surface.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 patients' limb.This will avoid problems caused by a tourniquet cuff that is too small or too large.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 that a pressure tourniquet cuff from the or did not work.The pressure tourniquet cuff failed before the surgery started.The tourniquet would not hold pressure.There was no patient injury or medical intervention and extended procedure time reported was 5 minutes.The risk to the patient was predicted as minimal by the surgeon, so the decision was made to continue without the use of a working tourniquet.There was an estimated 20 cc of blood loss and no transfusion was required.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: 7322429
• Report Number: 0001056128-2018-00011
• Device Sequence Number: 16545633
• Product Code: KCY
• UDI-Device Identifier: 00885825016142
• UDI-Public: (01)00885825016142(17)191114(10)7536813
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• Report Date (Section B): 03/07/2018

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: 11/14/2019
• Device Model Number: 5921-030-135
• Device Catalogue Number: 5921-030-135RR
• Device Lot Number: 7536813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1