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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT LINVATEC 10K / 24K ARTHROSCOPY INFLOW TUBING SET ARTHROSCOPE

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CONSOLIDATED MEDICAL EQUIPMENT LINVATEC 10K / 24K ARTHROSCOPY INFLOW TUBING SET ARTHROSCOPE Back to Search Results
Catalog Number 10K100
Device Problem Particulates (1451)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional product code; gcj. At time of filing, although expected, the reported device has not been returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
Conmed (b)(4) received a report of issues with the 10k100, linvatec 10k / 24k arthroscopy inflow tubing set, lot 202010154. It was reported that during proctology robotic surgery involving a (b)(6) female, white debris was found. The white debris was removed using a suction. The surgery was successfully completed without an alternative but with a 15minute delay. It is indicated that there was no impact or injury to the patient. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence due to the unknown foreign debris which was removed.
 
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Brand NameLINVATEC 10K / 24K ARTHROSCOPY INFLOW TUBING SET
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, mexico 31136
MX 31136
Manufacturer (Section G)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, mexico 31136
MX 31136
Manufacturer Contact
tracey weiselbenton
11311 concept blvd
largo, FL 33773-4908
7273995557
MDR Report Key11193346
MDR Text Key255490287
Report Number3007305485-2021-00028
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K033573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10K100
Device Lot Number202010154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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