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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SDC3 BASE SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE SDC3 BASE SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0240060100
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.(b)(4).
 
Event Description
It was reported that the sdc shut down in the middle of the case.
 
Event Description
It was reported that the sdc shut down in the middle of the case.
 
Manufacturer Narrative
Alleged failure: shuts down in the middle of cases.The failure alleged in the complaint record was not confirmed or duplicated during the product investigation.The probable root causes can be attributed to system overheating due to lint debris in the interior, or possibly due to issues with the software application, or system drivers.The product was returned for investigation and the failure mode was not confirmed and will be monitored for future reoccurrence.
 
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Brand Name
SDC3 BASE SYSTEM
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7485477
MDR Text Key107451561
Report Number0002936485-2018-00392
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
K160332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0240060100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Date Manufacturer Received04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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