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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX WECK HEM-O-LOCK

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TELEFLEX WECK HEM-O-LOCK Back to Search Results
Lot Number 73A1700205
Device Problems Break (1069); Detachment Of Device Component (1104); Defective Component (2292); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/24/2017
Event Type  Injury  
Event Description
Patient having laparoscopic cholecystectomy. During procedure, it was noted that the disposable weck hem-o-lock device had malfunctioned. Surgeon found the tip to be loose and it broke off in his hand. Second hem-o-lock was opened and found to be defective also - the clip would not open fully when it was engaged in the instrument. No harm to the patient.
 
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Brand NameWECK HEM-O-LOCK
Type of DeviceWECK HEM-O-LOCK
Manufacturer (Section D)
TELEFLEX
morrisville NC 27560
MDR Report Key6380648
MDR Text Key69252702
Report NumberMW5068274
Device Sequence Number1
Product Code HBQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/02/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number73A1700205
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
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