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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER,SURGICAL, CLIP
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TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER,SURGICAL, CLIP Back to Search Results
Catalog Number 544995
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
The applier could not be taken off the vessel after the clip was ligated during an operation.Additional information indicates no further intervention required; another applier was used to complete the procedure.The patient's condition was reported as good.
 
Manufacturer Narrative
(b)(4).The dhr for the instruments in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) facility as part of a (b)(4) lot in december of 2013.The returned instrument was evaluated and found that the knob rotation is slightly sluggish and the knob and back plug are discolored and faded.Further evaluation showed that this instrument picks up, retains, closes and releases clips as required of its function both with and without the use of silastic testtubing thus we are unable to validate the alleged complaint.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.At this time it is un-determined what caused the alleged issue.No corrective action required at this time.Other remarks: confirmed, but the root cause is unknown.
 
Event Description
The applier could not be taken off the vessel after the clip was ligated during an operation.Additional information indicates no further intervention required; another applier was used to complete the procedure.The patient's condition was reported as good.
 
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Brand Name
HOL L 10MM ENDO APPLIER
Type of Device
APPLIER,SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6089288
MDR Text Key59501368
Report Number3011137372-2016-00331
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544995
Device Lot Number06F1388075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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