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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC, CAMERA HEAD, NON-AC, HD560H; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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SMITH & NEPHEW, INC. SVC, CAMERA HEAD, NON-AC, HD560H; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 72200561S
Device Problem Electrical Shorting (2926)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2019
Event Type  malfunction  
Event Description
It was reported a shortage.No patient was involved.
 
Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of a short was confirmed.Product failed functional testing with intermittent live video output.There appears to be a short near strain relief.Cause of video malfunction is a defective cable assembly.Camera head passed functional testing with a known good cable assembly installed.Factors which can contribute to a shorted cord include rolling a heavy cart over the cord or excessive bending of the cord.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.
 
Event Description
It was reported a shortage in the camera head.No patient was involved.
 
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Brand Name
SVC, CAMERA HEAD, NON-AC, HD560H
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8624008
MDR Text Key145757074
Report Number1643264-2019-00361
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
K070266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200561S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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