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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER
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TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER Back to Search Results
Catalog Number 544965
Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2015
Event Type  malfunction  
Event Description
Alleged event: when the user moved the applier toward the patient's abdominal cavity after placing the clip on the applier, the clip tended to drop off easily.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).The device history record (dhr) for the instrument in question was reviewed and found complete without any irregularities.The returned instrument was evaluated and found that the jaws are aligned with each other and that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of its function.We are unable to validate the alleged complaint since we are unable to duplicate the alleged issue.Parts were 100% visually inspected and tested at the (b)(4) facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.No corrective action required at this time.
 
Event Description
Alleged event: when the user moved the applier toward the patient's abdominal cavity after placing the clip on the applier, the clip tended to drop off easily.The patient's condition was reported as fine.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck drive
research triangle park NC 27709
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key4912665
MDR Text Key6052479
Report Number1044475-2015-00196
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,company represent
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06B1498869
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Patient Sequence Number1
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