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

Model Number 0450000000

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the patient had swelling and post op pain.

Event Description

It was reported that the patient had swelling and post op pain.

Manufacturer Narrative

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: device malfunction probable root cause: pressure sensor malfunction/out of calibration.Inflow cassette/ tubing pressure sensor membrane failure.Mis-inserted cassette/ tubing.Motor encoder malfunction/failure.Roller wheel assembly malfunction/failure.Roller wheel failure due to peristaltic tubing debris build-up main board/imx failure.Software malfunction.Use error system design.Unwanted movement of internal components/wiring.Pressure sensor is operated above linear pressure reading range.Pump operated at least-favorable environmental conditions for extended period of time.Run screen does not adequately indicate overpressure situation.Miniwashmalfunction command not registered from hand control , footswitch, sidne or hermes excessive use of wash or turbo.Slow reaction time to a quickly closed off shaver outflow at high flow rates.Power failure of pump.Pressure sensor stuck behind the sensor bracket.Electromagnetic interference from rf communication, hf surgical instruments, esd, or power surge.Insufficient cybersecurity.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.H3 other text : 81.

• Brand Name: PKG, CROSSFLOW CONSOLE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11308694
• MDR Text Key: 231204475
• Report Number: 0002936485-2021-00076
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (y/n): N
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0450000000
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1