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

Model Number	60-7075-105
Medical Device Problem Codes	Component Missing (2306); Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 label and returned complaint device were verified.The label returned with the complaint device clearly stated that the device used a plc connector.The returned complaint device did in fact have a plc connector.The plc connector does not have or use an o-ring.A review of the dhr supports that the devices met all inspection and test criteria prior to release from stryker.The reported event could be attributed to user expectation.The instructions for use (ifu) state: before beginning the procedure, verify compatibility of all devices and accessories.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 the customer received a case of tourniquet cuffs without the black o-ring on the connecting tube.As reported, this resulted in the cuff not sealing properly and not properly inflating.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Event or Problem Description
It was reported that the customer received a case of tourniquet cuffs without the black o-ring on the connecting tube.As reported, this resulted in the cuff not sealing properly and not properly inflating.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
D4 expiration date, h4 manufacturing date, h6 device code grid, and h11 additional mfg narrative updated.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the label and returned complaint device were verified.The label returned with the complaint device clearly stated that the device used a plc connector.The returned complaint device did in fact have a plc connector.The plc connector does not have or use an o-ring.The returned complaint device had an expiration date of 1/30/2025, which meant the complaint device was already expired.A review of the dhr supports that the devices met all inspection and test criteria prior to release from stryker.The reported event could be attributed to user expectation.The instructions for use (ifu) state: before beginning the procedure, verify compatibility of all devices and accessories.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.

• 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: 22287653
• Report Number: 3020163307-2025-00005
• Device Sequence Number: 8310143
• Product Code: KCY
• UDI-Device Identifier: 00885825013936
• UDI-Public: 00885825013936
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 10/23/2025

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: 01/30/2025
• Device Model Number: 60-7075-105
• Device Catalogue Number: 60-7075-105
• Device Lot Number: 0000220217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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