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

Model Number	5921-034-135
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned, inspection was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported issue could be attributed to: under pressurized pressure tourniquet cuff; wrong size tourniquet cuff used; kink in tubing of ptc; ptc damaged or broken during use (leak); wrong size stockinette used; stockinette is not placed properly on limb; product damaged during shipping/ storage; inadequate handling instruction, user damages cuff; exposed to heat; loss of structural integrity.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.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported tourniquet cuff device had an o ring issue, not holding air.The complainant is not aware of any patient injury, medical intervention, or the duration of the extended procedure time.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: 16651446
• Report Number: 3020163307-2023-00173
• Device Sequence Number: 17480975
• Product Code: KCY
• UDI-Device Identifier: 00885825016173
• UDI-Public: 00885825016173
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 03/30/2023

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: 5921-034-135
• Device Catalogue Number: 5921-034-135RR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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