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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/01/1901
Type of Reportable Event Malfunction
Event or Problem 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.
 
Additional 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
Common Device Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7574094
Report Number3003604053-2018-00087
Device Sequence Number11391572
Product Code GCJ
UDI-Device Identifier00885554025897
UDI-Public(01)00885554025897
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K014158
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/29/2018
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
Operator of Device Health Professional
Device Model Number72203360S
Device Catalogue Number72203360S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Initial Date Received by Manufacturer 05/17/2018
Supplement Date Received by Manufacturer06/28/2018
Initial Report FDA Received Date06/06/2018
Supplement Report FDA Received Date06/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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