MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. ASSY. SUCTION IRRIGATOR 2; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0250070500
Medical Device Problem Codes	Leak/Splash (1354); Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the suction irrigator for was being used for 15-30 minutes, the tip started leaking.Staff attempted to unstick button, in case that was causing it to run and dispense saline outside patient, did not fix the issue.Surgeon observed that the tip was "smoking." at this time, suction irrigator was removed from sterile field, replaced with new device.Motor for irrigator was still running at this time, as if the button was fully depressed, battery compartment/motor where irrigator spikes saline bag hot to the touch.Therefore, there was a thermal event.
Event or Problem Description
It was reported that the suction irrigator for was being used for 15-30 minutes, the tip started leaking.Staff attempted to unstick button, in case that was causing it to run and dispense saline outside patient, did not fix the issue.Surgeon observed that the tip was "smoking." at this time, suction irrigator was removed from sterile field, replaced with new device.Motor for irrigator was still running at this time, as if the button was fully depressed, battery compartment/motor where irrigator spikes saline bag hot to the touch.Therefore, there was a thermal event.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure : tip was smoking probable root cause for equipment leaks and flow too high : 1.Material/design error 2.Constant irrigation flow is not maintained leading to limited field of view 3.Stopcocks in improper configuration 4.Large anatomy 5.Missing o-ring 6.Damaged or deformed o-ring 7.Pump malfunction (motor, control board, harness, power supply, battery, or cassette) 8.Clogged tubing 9.User error probable root cause for smoke smell or flames coming from device : 1.Insulation melting 2.Excessive cauterization 3.User error 4.Nonconforming electrical components probable root cause for overheating: 1.Material/design error 2.User error the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG. ASSY. SUCTION IRRIGATOR 2
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22457387
• Report Number: 0002936485-2025-00616
• Device Sequence Number: 20862751
• Product Code: GCJ
• UDI-Device Identifier: 37613327061391
• UDI-Public: 37613327061391
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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 Catalogue Number: 0250070500
• Device Lot Number: 24338FG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female