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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1288210105
Device Problem Fogging (1253)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was fogging during a procedure, which could not be wiped away.
 
Manufacturer Narrative
Alleged failure: blurry foggy image.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: the most likely root causes for the issues found could be wear and tear and/or by the cable being pulled or bent hard during sterilization.Camera head is not producing a blurry foggy image.The cause of the blurry foggy image is the coupler.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that there was fogging during a procedure, which could not be wiped away.
 
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Brand Name
PKG 1288HD CAMERA HEAD
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9459370
MDR Text Key176658265
Report Number0002936485-2019-00544
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327063424
UDI-Public07613327063424
Combination Product (y/n)N
PMA/PMN Number
K132785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1288210105
Device Catalogue Number1288210105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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