MAUDE Adverse Event Report: STRYKER-ENDOSCOPY TIJUANA MX; TOURNIQUET, PNEUMATIC

Model Number	5921-034-235
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a defective cuff.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The returned complaint device revealed one reprocessing dot.Inspection of the connector junctions, revealed no separation (visually).The connectors had no visual signs of damage.The tubing was discolored with no visual kinks, bends, or distress.The entirety of the cuff revealed no obvious signs of rips, tears, piling, fraying, or lacerations.Functional testing was performed.The compressed air was set to 300.1mmhg for testing purposes and measured using calibrated manometer.The complaint device was connected to the device under testing (dut) tubing set.The ball valve was then opened to allow for the complaint device to fill and stabilize.Immediately an audible leak was heard and the cuff deflated quickly.The cuff was submerged in water to pinpoint the origin of the leak.A leak was found at the edge of the bladder seal.A review of the dhr a review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.The reported event could be attributed to: ptc damaged or broken during use (leak).The instructions for use (ifu) state: 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.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.

• Brand Name: NA
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana 22643 ; MX 22643
• Manufacturer (Section G): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana 22643 ; MX 22643
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 25463740
• Report Number: 3020163307-2026-00007
• Device Sequence Number: 16036207
• Product Code: KCY
• UDI-Device Identifier: 00885825016197
• UDI-Public: 00885825016197
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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 Model Number: 5921-034-235
• Device Catalogue Number: 5921-034-235
• Device Lot Number: 0001269171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown