MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; 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	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device leaked and could not maintain pressure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation as the device was not kept.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: ptc coming into contact with sharp object or surface.Product damaged during shipping/storage.Loss of structural integrity.Inadequate handling instruction, user damages cuff.The instructions for use (ifu) state: 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.
Additional Manufacturer Narrative
On 04/18/2023, stryker sustainability solutions became aware that mdr section d3 (manufacturer entity) and d7b (reprocessor name & location) were not completed correctly for this mdr.This supplemental mdr serves to provide the corrected information.The reported event will continue to be monitored through post market surveillance.
Event or Problem Description
It was reported the device leaked and could not maintain pressure.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; col. leandro valle, baja ca; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; col. leandro valle, baja ca; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 16686288
• Report Number: 3020163307-2023-00184
• Device Sequence Number: 12804914
• Product Code: KCY
• UDI-Device Identifier: 00885825016166
• UDI-Public: 00885825016166
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/09/2023

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: 12/21/2023
• Device Model Number: 5921-030-235
• Device Catalogue Number: 5921-030-235RR
• Device Lot Number: 13469459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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