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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
Model Number 72201919
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during set up of a knee procedure, white smoke came out from the cooling hole after the camera control unit was turned on.Although no delay was reported, it is unknown if a back up device was available.No patient injury or other complications were reported.
 
Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event, since it was confirmed that the device had no sparks or overheating.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference: (b)(4).
 
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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
MDR Report Key12249310
MDR Text Key264245950
Report Number1643264-2021-02233
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72201919
Device Catalogue Number72201919
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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