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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - FLUID MANAGEMENT SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

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DEPUY MITEK LLC US UNK - FLUID MANAGEMENT SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Catalog Number UNK - FLUID MANAGEMENT
Device Problems Crack (1135); Leak/Splash (1354); Moisture Damage (1405)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown fluid management system. Part and lot number are unknown. Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the customer in (b)(6) that during a knee arthroscopy procedure on (b)(6) 2021, it was observed that an unknown arthroscopic pump with irrigation tubing device was leaking; and that the camera was flooded with water. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.
 
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Brand NameUNK - FLUID MANAGEMENT
Type of DeviceSURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12667521
MDR Text Key277723826
Report Number1221934-2021-03082
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberUNK - FLUID MANAGEMENT
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unkown

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