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

Model Number	60-7070-106
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had an air leak.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 investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.H3 other text : 81.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, one of the plc connectors was missing.The returned tubing, without the plc connector had a visual imprint of where the plc connector once rested.Functional testing was unable to be performed as the complaint device was received without one of the plc connectors.The device 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 may be attributed to inadequate handling subsequent to distribution from stryker's sustainability solutions.The instructions for use (ifu) state: directions for use: 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 the device had an air leak.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 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: 17834347
• Report Number: 3020163307-2023-00222
• Device Sequence Number: 20687454
• Product Code: KCY
• UDI-Device Identifier: 00885825013875
• UDI-Public: 00885825013875
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/23/2023

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
• Device Model Number: 60-7070-106
• Device Catalogue Number: 60-7070-106RR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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