MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, FLOSTEADY - ARTHROSCOPY POLE PUMP; ARTHROSCOPE

Model Number	0350800001
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the pressure was higher than intended.There were no adverse consequences or medical intervention and the procedure was completed successfully.
Additional 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: pump will increase in pressure unintendedly.Probable root cause: pressure sensor malfunction/out of calibration.Inflow cassette/ tubing pressure sensor membrane failure.Mis-inserted cassette/ tubing.Motor encoder malfunction/failure (inflow and/or outflow).Roller wheel assembly (inflow and/or outflow) malfunction/failure.Roller wheel failure due to peristaltic tubing debris build-up.Main board (all) /imx failure (cf).Software malfunction (1, 3, 3.1, 3.4, 3.15, 3.16, 3.17, 4,, 8 for cf, or related modules in other pumps).Use error system design unwanted movement of internal components/wiring pressure sensor is operated above linear pressure reading range (>450 mmhg for cf) (design).Pump operated at least-favorable environmental conditions for extended period of time run screen does not adequately indicate overpressure situation miniwashmalfunction (cf).Command not registered from hand control (all), footswitch (cf), sidne (fc, ap) or hermes (ap-hermes ready) 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 (emi) from rf communication, hf surgical instruments, esd, or power surge insufficient cybersecurity (cf).The manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the pressure was higher than intended.There were no adverse consequences or medical intervention and the procedure was completed successfully.

• Brand Name: PKG, FLOSTEADY - ARTHROSCOPY POLE PUMP
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12132291
• Report Number: 0002936485-2021-00367
• Device Sequence Number: 1323633
• Product Code: HRX
• UDI-Device Identifier: 07613327057522
• UDI-Public: 07613327057522
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K062380
• 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): 09/08/2021

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 Model Number: 0350800001
• Device Catalogue Number: 0350800001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1