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

Catalog Number	60-7080-102
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tourniquet cuff came out of the package with leaks.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the complaint device is a dual bladder ptc.Inspection of the connector tips and junctions, revealed no evidence of damage or separation with the naked eye.The tubing was discolored with no visual kinks, bends, or distress.The entirety of the cuff revealed no obvious signs of rips, tears, fraying, or lacerations, but did reveal slight pilling.Functional testing was performed using the bpc-ptc flow tester.The compressed air was set to 300.6mmhg for testing purposes and measured using a 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.Note, this is a dual bladder ptc.Bladder a remained fully inflated with no audible leaks heard, but the inflation rate of quickly dropped to 288.8mmhg with an analog leak flow rate greater than 1.0mmhg.Bladder a was submerged below water and a visible leak, indicated by air bubbles came from one of the connector junctions.Bladder b (blue) was tested using the same approach.The cuff was fully inflated, but the inflation rate of quickly dropped to 297.3mmhg with an analog leak flow rate of 0.6mmhg.Bladder b was submerged in water with no indication of leaks.The results of the visual inspection and functional testing determined that the reported event was confirmed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: product damaged during shipping/storage.Inadequate handling instruction, user damages cuff.Loss of structural integrity.Degradation of adhesive.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.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 the tourniquet cuff came out of the package with leaks.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• 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
• Manufacturer (Section G): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 23128304
• Report Number: 3020163307-2025-00013
• Device Sequence Number: 9298148
• Product Code: KCY
• UDI-Device Identifier: 00885825013547
• UDI-Public: 00885825013547
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/23/2025

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 Catalogue Number: 60-7080-102
• Device Lot Number: 0000786738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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