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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 4MM AUTOCLAVABLE ARTHROSCOPE
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STRYKER ENDOSCOPY-SAN JOSE PKG., 4MM AUTOCLAVABLE ARTHROSCOPE Back to Search Results
Model Number 0502477031
Device Problems Poor Quality Image (1408); Optical Problem (3001)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
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.
 
Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in india.The technical service report is attached (see communication log), and indicates: scope is damaged and not repairable.Probable root cause: ¿ incorrectly assembled optical train.¿ damage to optical train.¿ end of life wear-out.¿ shipping damage.¿ use error.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.
 
Event Description
It was reported that there was blurry image.
 
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Brand Name
PKG., 4MM AUTOCLAVABLE ARTHROSCOPE
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key11346403
MDR Text Key233784710
Report Number0002936485-2021-00098
Device Sequence Number1
Product Code HRX
UDI-Device Identifier07613327059137
UDI-Public07613327059137
Combination Product (y/n)N
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0502477031
Device Catalogue Number0502477031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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