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

Model Number	5921-030-235
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.H3 other text : 81.
Event or Problem Description
It was reported the device was leaking.There was no patient injury or medical intervention reported.The complainant is not aware of any extended procedure time.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
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 velcro strap, hooks and loop had pilling on them.The entirety of the cuff appeared to be intact with no obvious signs of rips, tears, fraying, or lacerations.The ptc showed a loss below the 2% limit of 0.9, therefore, passing the leak test.However, in light of information provided by our 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 of leak.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.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 the device was leaking.There was no patient injury or medical intervention reported.The complainant is not aware of any 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: 17187672
• Report Number: 3020163307-2023-00213
• Device Sequence Number: 14891706
• Product Code: KCY
• UDI-Device Identifier: 00885825016166
• UDI-Public: 00885825016166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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 Expiration Date: 05/02/2025
• Device Model Number: 5921-030-235
• Device Catalogue Number: 5921-030-235RR
• Device Lot Number: 0000280188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• 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