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

Model Number	0350800001
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was overpressure.The procedure was completed successfully with no medical intervention or adverse consequences.
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 there was overpressure.The procedure was completed successfully with no medical intervention or adverse consequences.
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: issues with pressure.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 , 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 reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13562647
• Report Number: 0002936485-2022-00098
• Device Sequence Number: 4340325
• Product Code: HRX
• UDI-Device Identifier: 07613327057522
• UDI-Public: 07613327057522
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 90 KG