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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tourniquet cuff was leaking and would not hold pressure.As reported, it was found to be a leak in the crease.There was no patient injury or medical intervention and extended procedure time reported was fifteen minutes.These are commonly used devices that are readily available.
Event or Problem Description
It was reported that the tourniquet cuff was leaking and would not hold pressure.As reported, it was found to be a leak in the crease.There was no patient injury or medical intervention and extended procedure time reported was fifteen minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - ptc damaged or broken during use (leak) - product damaged during shipping / storage - inadequate handling instruction, user damages cuff - loss of structural integrity 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.Should the device become available for return, the investigation will be reopened.

• 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: 21757277
• Report Number: 3020163307-2025-00003
• Device Sequence Number: 8263970
• Product Code: KCY
• UDI-Device Identifier: 00885825016197
• UDI-Public: 00885825016197
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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
• Device Model Number: 5921-034-235
• Device Catalogue Number: 5921-034-235
• Device Lot Number: 0000749228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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