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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL CAMERA HEAD HD 1200 AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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SMITH & NEPHEW, INC. SVCE REPL CAMERA HEAD HD 1200 AC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 72203360S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/1901
Event Type  malfunction  
Event Description
It was reported that there was a delay when pressing the bottom to take the picture.No back up device was available.No patient injury was reported.
 
Manufacturer Narrative
An evaluation was performed by smith & nephew and could not confirm the customer complaint for there was a delay when pressing the button to take the picture.This device was shipped 12/22/2015.A visual inspection was performed and showed scratches on the camera head lens with a baked on residue.The camera head was functionally tested and there was no delay when taking the pictures.No manufacturing related defects were observed.Date of event is unknown.
 
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Brand Name
SVCE REPL CAMERA HEAD HD 1200 AC
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7574094
MDR Text Key110380528
Report Number3003604053-2018-00087
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00885554025897
UDI-Public(01)00885554025897
Combination Product (y/n)N
PMA/PMN Number
K014158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72203360S
Device Catalogue Number72203360S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Date Manufacturer Received06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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