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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG
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SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG Back to Search Results
Catalog Number 72202961S
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a shoulder procedure, spots were noticed on the scope lens causing a complete loss of visualization during the surgery.A backup device was available to complete the procedure with no delay or patient injuries.
 
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for there was spots on the lens.A visual inspection was performed and showed the scope to have distal tip damage and scratches on the negative lens.This damage is caused by contact with another source.No manufacturing related defects were observed.
 
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Brand Name
VIDEOARTHROSCOPE HD 4MM X 30 DEG
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key8873326
Report Number3003604053-2019-00088
Device Sequence Number14087539
Product Code HRX
UDI-Device Identifier00885554024203
UDI-Public00885554024203
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K043395
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/26/2019
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 Catalogue Number72202961S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2019
Initial Date Received by Manufacturer 08/07/2019
Supplement Date Received by Manufacturer08/23/2019
Initial Report FDA Received Date08/08/2019
Supplement Report FDA Received Date08/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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