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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 72204354
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2020
Event Type  malfunction  
Event Description
It was reported that, during an arthroscopy, the lens integrated system had no light emission.There was a backup device available.No significant delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
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Brand Name
LENS INTEGRATED SYSTEM WIFI VERSION
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10587697
MDR Text Key208572790
Report Number1643264-2020-01291
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00885556617878
UDI-Public00885556617878
Combination Product (y/n)N
PMA/PMN Number
K153606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/28/2020
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
Device Operator Health Professional
Device Model Number72204354
Device Catalogue Number72204354
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/03/2020
Initial Date FDA Received09/25/2020
Supplement Dates Manufacturer Received10/26/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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