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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 ARTHROSCOPE

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SMITH & NEPHEW, INC. SERVICE REPL CAMERA HEAD LENS INT SYS ARTHROSCOPE Back to Search Results
Model Number 72203967S
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during set up or inspection, the camera head was not working properly. Connection was not working. The procedure was completed with a s+n back up device. No delay and no patient injury or other complications were reported.
 
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Brand NameSERVICE REPL CAMERA HEAD LENS INT SYS
Type of DeviceARTHROSCOPE
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 Key11952783
MDR Text Key255369538
Report Number1643264-2021-02085
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72203967S
Device Catalogue Number72203967S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
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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