MAUDE Adverse Event Report: STRYKER-ENDOSCOPY TIJUANA MX DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Model Number	5921-034-235
Medical Device Problem Codes	Leak/Splash (1354); Decrease in Pressure (1490)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use in a procedure at the user facility.The tourniquet cuff would not hold air properly and the patient had more bleeding during the procedure and more cauterization was needed than usual during the procedure.
Additional Manufacturer Narrative
Updates made to fields: d3, d4, d7, g1, g3, g6, h2, h3, h6, h8, & h10, the device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the elbow junctions and tubing to cuff adapters revealed no separation.The quick connect o-rings and overall integrity of the connectors appeared to be in-tact with no visual indication of damage.The tubing was clear with no visual kinks, bends, or distress.The entirety of the cuff appeared to be intact with no obvious signs of rips, tears, pilling, fraying, or lacerations.The returned complaint device passed functional testing.However, in light of information provided by field service representatives, the reported event was able to be replicated by closing the receiving connector end(s) and/or angling the quick connect and forcing the dislodging of the o-ring(s), thereby confirming the reported event.A review of the dhr could not be performed as the lot number was not reported.Therefore, the most likely root cause is improper connection to pump.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 during use in a procedure at the user facility.The tourniquet cuff would not hold air properly and the patient had more bleeding during the procedure and more cauterization was needed than usual during the procedure.

• Brand Name: DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana MI 22643
• Manufacturer (Section G): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana 00615
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 16755817
• Report Number: 3015967359-2023-00749
• Device Sequence Number: 19652509
• Product Code: KCY
• UDI-Device Identifier: 00885825016197
• UDI-Public: 00885825016197
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 5921-034-235
• Device Catalogue Number: 5921034235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 08/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown