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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE ARTHROSCOPE Back to Search Results
Catalog Number 0450000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Chemical Exposure (2570)
Event Date 09/14/2018
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that non-sterile fluid entered the nurses eyes.
 
Event Description
It was reported that non-sterile fluid entered the nurses eyes.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed. Alleged failure: non-sterile fluid got in nurse's eye. 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. Miniwash malfunction (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. The reported failure mode will be monitored for future reoccurrence.
 
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Brand NamePKG, CROSSFLOW CONSOLE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7949810
MDR Text Key123191098
Report Number0002936485-2018-00638
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0450000000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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