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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C

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STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C Back to Search Results
Model Number 0502904030
Device Problems No Display/Image (1183); Optical Problem (3001)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
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 blurry image during procedure.
 
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Brand NamePKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key12333815
MDR Text Key268315509
Report Number0002936485-2021-00428
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0502904030
Device Catalogue Number0502904030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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