MAUDE Adverse Event Report: Stryker-Endoscopy Tijuana MX; tourniquet, pneumatic

Model Number	5921-030-236
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction

• 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 ; +1(888)888-3433
• MDR Report Key: 50796812
• Report Number: 3020163307-2026-00012
• Device Sequence Number: 9570266
• Product Code: KCY
• UDI-Device Identifier: 00885825016432
• UDI-Public: 00885825016432
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/16/2026

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: 5921-030-236
• Device Catalogue Number: 5921-030-236
• Device Lot Number: Not reported
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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