MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG CROSSFLOW CONSOLE; ARTHROSCOPE

Catalog Number	0450000000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump was set very low starting at 35 and then bumping it down to 15 but pump seemed to be pumping very hard even with lowering pressure.After the case the patient experienced a lot of swelling and had to be admitted until they recovered.Patient had to stay the night to monitor the swelling.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the pump was set very low starting at 35 and then bumping it down to 15 but pump seemed to be pumping very hard even with lowering pressure.After the case the patient experienced a lot of swelling and had to be admitted until they recovered.Patient had to stay the night to monitor the swelling.
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: patient experienced a lot of swelling probable root cause: 1.Pressure sensor malfunction/out of calibration.2.Inflow cassette/ tubing pressure sensor membrane failure.3.Mis-inserted cassette/ tubing.4.Motor encoder malfunction/failure (inflow and/or outflow).5.Roller wheel assembly (inflow and/or outflow) malfunction/failure.6.Roller wheel failure due to peristaltic tubing debris build-up.7.Main board (all) /imx failure (cf).8.Software malfunction.9.Use errors: user opens pump console/hand control/footswitch.User modifies console/hand control/footswitch and/or components.User applies force to components when reaching hand inside cassette housing.User places foreign substance/material into cassette housing.User drops pump/hand control/footswitch or inflicts other exterior damage during handling or transit incorrect scope/cannula hardware combination chosen.Joint height and pump height difference is greater than 12 inches hand control/footswitch/power/integration cable or usb mis-inserted into console wrong application software uploaded via usb cassette/ tubing partially inserted hand control/footswitch/power/integration cable pulled from cable instead of connector rf/shaver integrated console plugged into the wrong receptacle in the back of the pump hand control is plugged into a pump outside of its intended use pressure settings are incorrect for type or length of procedure, condition of patient, or surgical technique employed flow rate/suction settings are too high or too low for type or length of procedure, condition of patient, or surgical technique employed wash pressure/flow settings set higher than appropriate for type or length of procedure, condition of patient, or surgical technique employed both stopcocks open for a duration of time longer than a few seconds when using a non-inflow/outflow dual-stopcock cannula and suction attached to the second stopcock product used past recommended maintenance or service period without servicing or inspection.Shaver suction lever left closed or rf probe pinch clamp left closed hand control sterilized using incompatible methods footswitch sterilized hand control left in sterilization chamber for longer than necessary to reprocess sterilization instructions in the ifu not followed (placement in tray, # of units, etc.) console cleaned using incompatible methods hand control or footswitch cleaned using incompatible methods abrasive brushes or pads used to clean console, hand control, or footswitch 10.System design.11.Unwanted movement of internal components/wiring.12.Pressure sensor is operated above linear pressure reading range (>450 mmhg for cf) (design).13.Pump operated at least-favorable environmental conditions for extended period of time.14.Run screen does not adequately indicate overpressure situation.15.Miniwashmalfunction (cf).16.Command not registered from hand control (all), footswitch (cf), sidne (fc, ap) or hermes (ap-hermes ready).17.Excessive use of wash or turbo 18.Slow reaction time to a quickly closed off shaver outflow at high flow rates.19.Power failure of pump.20.Pressure sensor stuck behind the sensor bracket.21.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.22.Insufficient cybersecurity (cf).The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG CROSSFLOW CONSOLE
• Common Device Name: ARTHROSCOPE
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 24059219
• Report Number: 0002936485-2026-00026
• Device Sequence Number: 15921506
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown