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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD LENS INT SYS ARTHROSCOPE

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SMITH & NEPHEW, INC. CAMERA HEAD LENS INT SYS ARTHROSCOPE Back to Search Results
Catalog Number 72203967
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  malfunction  
Event Description
It was reported that, during a procedure, the camera head lens integrated system stopped displaying the surgical image and displayed colored bars on the screen. The device malfunctioned twice in the same case, so it was used a back-up device available to complete the case. Neither surgical delay nor patient injuries were stated.
 
Manufacturer Narrative
There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the exterior of the product and no physical damage was observed. The complaint of live image switching to color bars could not be duplicated during the functional testing process. The camera head passed functional testing and 6 hour burn in inside test video tower. All functions perform as expected and live video image was normal. The complaint of live image switching to color bars was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process. 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.
 
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Brand NameCAMERA HEAD LENS INT SYS
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8205988
MDR Text Key131906653
Report Number1643264-2018-01013
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72203967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
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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