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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMLOK CLIPS; HEMOCLIPS
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HEMLOK CLIPS; HEMOCLIPS Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Stenosis (2263)
Event Date 01/01/2009
Event Type  malfunction  
Event Description
Alleged issue: kevin blumenthal and et al, dept of urol, george washington hospital in washington, dc described reviewing cases of patients who underwent robot-assisted laparoscopic radical prostatectomy (ralp) at the institution from january 2004 to september 2007 and identified patients with bladder neck contractures (bnc) or complications related to the use of holc.A retrospective chart review was performed to attempt to determine the cause of each bnc.Below are the findings of 524 patients that had undergone ralp: 2 bncs were associated with holc migration and erosion into the vesicourethral anastomosis.
 
Manufacturer Narrative
The device history record review (dhr) could not be conducted since the lot number was not provided.Complaint can not be confirmed since the sample was not available for investigation.The manufacturer will continue to monitor and trend relating complaints.
 
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Brand Name
HEMLOK CLIPS
Type of Device
HEMOCLIPS
Manufacturer Contact
effie jeferson, rn
po box 12600
durham, NC 27709
9194332672
MDR Report Key3908402
MDR Text Key4665976
Report Number3003898360-2014-00359
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/01/2014
Initial Date FDA Received06/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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