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	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the elbow junction and tubing to cuff adapter revealed no separation.The quick connect o-ring and overall integrity of the connector appeared to be in-tact with no visual indication of damage.The tubing was clear with no visual kinks, bends, or distress.The ribbon end of the cuff revealed a large bladder laceration.As the bladder was lacerated, functional testing was unable to be performed to investigate the complaint.The visual inspection indicated that the complaint was confirmed for the reported failure mode.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 mishandling post distribution from stryker's sustainability solutions.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 placed on patient per protocol but it was unable to inflate when the doctor needed to start the surgical procedure.It was attempted to replace the tourniquet, tubing, cords, but the device was still unable to inflate.The doctor started surgery without the device and complained of increased bleeding during procedure (300ml).No transfusion was required.It was reported the patient was sent to pacu after procedure with no issues and no patient harm and that nothing in the chart gave any impression of adverse consequences, unanticipated medical procedures, or additional treatments.No delay was noted and thus no significant need for added sedation/anesthesia.The patient was reported to have been transferred to recovery in stable condition with no complications.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: 16763137
• Report Number: 3020163307-2023-00200
• Device Sequence Number: 16883897
• 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): 04/18/2023

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: 10/26/2024
• Device Model Number: 5921-034-135
• Device Catalogue Number: 5921-034-135RR
• Device Lot Number: 0000193840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White