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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL ASCOPE ACLV 2.7 X ARTHROSCOPE

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SMITH & NEPHEW, INC. SVCE REPL ASCOPE ACLV 2.7 X ARTHROSCOPE Back to Search Results
Model Number 7205682S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case (b)(4). The reported device, used in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection found distal tip and fiber damage and cracked distal lens with scratches. The complaint was confirmed. Factors that could have contributed to the reported event include an impact event inconsistent with normal use.
 
Event Description
It was reported that during knee arthroscopy procedure, the scope had the lens cracked. No delay and a back up was available to complete the procedure. No other complications were reported. Results of investigation have concluded that this scope had a cracked on the distal lenses which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameSVCE REPL ASCOPE ACLV 2.7 X
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 Key11357542
MDR Text Key232816408
Report Number3003604053-2021-00053
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205682S
Device Catalogue Number7205682S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
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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