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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1.9MM X 30A TMJ, SPEEDLOCK, A/C; ARTHROSCOPE
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STRYKER ENDOSCOPY-SAN JOSE PKG, 1.9MM X 30A TMJ, SPEEDLOCK, A/C; ARTHROSCOPE Back to Search Results
Model Number 0502144030
Device Problems Poor Quality Image (1408); Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2020
Event Type  malfunction  
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 Description
It was reported that there was a poor image.
 
Manufacturer Narrative
Alleged failure: detached internal lenses.Probable root cause: poor mate between cannula and endoscope (i.E.Speedlock or j-lock feature), poor fit between endoscope needle and cannula, use error.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
 
Event Description
It was reported that there was a poor image.
 
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Brand Name
PKG, 1.9MM X 30A TMJ, SPEEDLOCK, A/C
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key10583116
MDR Text Key208789974
Report Number0002936485-2020-00393
Device Sequence Number1
Product Code HRX
UDI-Device Identifier07613327053548
UDI-Public07613327053548
Combination Product (y/n)N
PMA/PMN Number
K093677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0502144030
Device Catalogue Number0502144030
Was Device Available for Evaluation? No
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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