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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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SMITH & NEPHEW, INC. CAMERA CONTROL UNIT, HIGH DEF, 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 72201919
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 09/02/2019
Event Type  malfunction  
Event Description
It was reported that when the device was being connected before the operation the host smoked and shut down automatically.No patient was involved as the failure was found before the surgery.
 
Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
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Brand Name
CAMERA CONTROL UNIT, HIGH DEF, 560P
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8966942
MDR Text Key156661094
Report Number1643264-2019-00628
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier03596010643094
UDI-Public03596010643094
Combination Product (y/n)N
PMA/PMN Number
K070266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72201919
Was Device Available for Evaluation? No
Date Manufacturer Received10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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