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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 Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2020
Event Type  Injury  
Event Description
It was reported that the surgeon forcefully inserted the scope/cannula via slotted cannula as a guide. There was a slight internal crack of distal scope lens. Likely, due to the amount of pressure the slotted cannula placed on the scope lens. The malfunction was solved with a delay shorter than 30 minutes with no patient harm using a back up device. 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
MDR Report Key10491718
MDR Text Key205657006
Report Number3003604053-2020-00096
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2021
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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