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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1488010001
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)
Patient Problem Shock (2072)
Event Date 01/29/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that a user was shocked.
 
Manufacturer Narrative
Alleged failure: todd or shocked when plugged in.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: camera head conforms to specifications.The most provable root cause could be damaged power cord or electrical static discharge when connecting the unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
 
Event Description
It was reported that a user was shocked.
 
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Brand Name
PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9750878
MDR Text Key184259841
Report Number0002936485-2020-00078
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327061017
UDI-Public07613327061017
Combination Product (y/n)N
PMA/PMN Number
K132785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/09/2020
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 Model Number1488010001
Device Catalogue Number1488010001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Initial Date Manufacturer Received 01/29/2020
Initial Date FDA Received02/25/2020
Supplement Dates Manufacturer Received01/29/2020
Supplement Dates FDA Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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