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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASCOPE ACLAVE HD 4MM X 70 DEG ARTHROSCOPE

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SMITH & NEPHEW, INC. ASCOPE ACLAVE HD 4MM X 70 DEG ARTHROSCOPE Back to Search Results
Model Number 72202088
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 09/23/2020
Event Type  Injury  
Event Description
It was reported that during the set up before a hip scope, the scope had an unspecified functional failure. A delay greater than 30 minutes was reported and the patient was already under anesthesia. Another smith and nephew back-up device with a different part number was used to complete the surgery. No other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameASCOPE ACLAVE HD 4MM X 70 DEG
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10702885
MDR Text Key212078301
Report Number3003604053-2020-00133
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202088
Device Catalogue Number72202088
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/20/2020 Patient Sequence Number: 1
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