• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 5MM 0° LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ENDOSCOPY-SAN JOSE HD 5MM 0° LAPAROSCOPE, AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0502539010
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2019
Event Type  malfunction  
Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported the scope had a cloudy image during use, procedure completed successfully with a replacement scope.
 
Manufacturer Narrative
Alleged failure: cloudy.Probable root cause: ¿ laser welding seal failure ¿ distal/proximal window solder failure ¿ damage to optical train ¿ damage to needle ¿ damage to distal or proximal windows ¿ moisture intrusion ¿ end of life wear-out ¿ environmental disturbance: endoscope colder than dew point ¿ environmental disturbance: fluid entrapment between the coupler and eyepiece junction (eyepiece only) ¿ 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.The device manufacturer date is not known.
 
Event Description
It was reported the scope had a cloudy image during use, procedure completed successfully with a replacement scope.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HD 5MM 0° LAPAROSCOPE, AC
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key8608027
MDR Text Key145095183
Report Number0002936485-2019-00204
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327059403
UDI-Public07613327059403
Combination Product (y/n)N
PMA/PMN Number
K910132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0502539010
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received05/14/2019
Supplement Dates Manufacturer Received04/15/2019
Supplement Dates FDA Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-