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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 72203967S
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 05/04/2020
Event Type  Malfunction  
Event Description

It was reported that the camera head lens was not working. No case reported; therefore, there was no patient involvement. Preliminary results of investigation have showed that the camera head live video was intermittent which made this a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameSERVICE REPL CAMERA HEAD LENS INT SYS
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10261804
MDR Text Key198488725
Report Number1643264-2020-00533
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK153606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72203967S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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