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

Catalog Number	0350800001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg date: the device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that over-pressure was experienced with the pump.
Additional Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: dr (b)(6) uses the flosteady pump routinely.Pump settings 45 p and 1.5 flo which is default for the knee.Pump was primed as usual and seemed to be fine.It was then reported by dr (b)(6) that fluid was coming out of the port side at a abnormally high pressure and the pump pressure seemed to be much higher than it was reading on the pump.Dr (b)(6) then lowered pump pressure from 45 to 30 then to 25 and finally to 15 but this did not change the amount of fluid squirting from the port site.Another pump serial (b)(4) was brought in and pump tubing changed but still the pressure was higher than normal and squirted out of the port site at an abnormally high rate.The procedure was completed and the patient is being observed for potential compartment syndrome.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be overdue calibration, pressure sensor, roller wheel, pcb board, pump height, joint height, the stop cock valves were closed off, tubing was kinked, or user misuse.Manufacture date is not known.
Event or Problem Description
It was reported that over-pressure was experienced with the pump.

• 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: 7543098
• Report Number: 0002936485-2018-00457
• Device Sequence Number: 19340202
• Product Code: HRX
• UDI-Device Identifier: 07613327057522
• UDI-Public: 07613327057522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/13/2018

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 Catalogue Number: 0350800001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1