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

Catalog Number	0350800001
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Edema (1820)
Date of Event	09/02/2019
Type of Reportable Event	Serious Injury
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 edema of the tissues occurred.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: ["we make a verification of the equipment according to the user manual.We use the verification kit with dry precision.The values are within the established ranges, over the lower limit according to the 10% margin of error, video recording of the procedure is made]" 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.
Event or Problem Description
It was reported that edema of the tissues occurred.

• 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: 9134966
• Report Number: 0002936485-2019-00429
• Device Sequence Number: 3031206
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/19/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other