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	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
Alleged failure: cib ari p sm pump will skyrocket to high pressure out of the blue po# temp the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be out of calibration, pressure sensor, pcb board, user error, or possible user misuse.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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: 12132240
• Report Number: 0002936485-2021-00364
• Device Sequence Number: 19202547
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• 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: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1