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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 70 DEG 4MM ARTHROSCOPE

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SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 70 DEG 4MM ARTHROSCOPE Back to Search Results
Model Number 72202088S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
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 damage, fiber damage, and a cracked and scratched distal lens.  a review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.  a complaint history review concluded this was a repeat issue. The complaint was confirmed. Factors that could have contributed to the reported event include an impact event inconsistent with normal use. Internal complaint reference: (b)(4).
 
Event Description
It was reported that during a hip scope surgery the scope lens was scratched. No patient injuries or delay reported. Unknown how the surgery was completed. Results of investigation have concluded that this unit had a cracked distal lens 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 NameSERV REPL ASCOPE A/C HD 70 DEG 4MM
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 Key11516219
MDR Text Key242728550
Report Number3003604053-2021-00099
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 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202088S
Device Catalogue Number72202088S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
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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