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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 30 DEG 4MM ARTHROSCOPE

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SMITH & NEPHEW, INC. SERV REPL ASCOPE A/C HD 30 DEG 4MM ARTHROSCOPE Back to Search Results
Model Number 72202087S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident.  a visual inspection found a cracked distal lens and negative lens damage. 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: case-(b)(4).
 
Event Description
It was reported that the arthroscope was found to have damage to the negative lens. No case reported. Results of investigation have concluded that this unit had a cracked distal lens which makes it a reportable event.
 
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Brand NameSERV REPL ASCOPE A/C HD 30 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 Key11947694
MDR Text Key254586609
Report Number3003604053-2021-00217
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202087S
Device Catalogue Number72202087S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
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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