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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Model Number IPN915189
Device Problem Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
At the time of the preparation of the procedure, the device was opened and its operation verified which showed that it was not working correctly since the clips cannot be placed.It would not load the clip.
 
Manufacturer Narrative
(b)(4).The device history review for the late returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc.Lot in june of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the instrument as returned shows that the handle to jaw and knob rotation mechanisms were both sluggish and binding.We are able to validate this complaint.After the evaluation non-silicone-based instrument lube was applied to the jaw mechanism and knob rotation mechanism and normal function was restored to both.This instrument is not able to pick-up, retain, close , and release multiple clips both with and without the use of silastic test tubing as required of its function.We are unable to determine what caused these instruments mechanisms to become dry and sluggish feeling, but lack of proper lubrication as instructed in ifu l02525 r02 which was supplied with the instrument at the time of manufacture is suspected.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.
 
Event Description
At the time of the preparation of the procedure, the device was opened and its operation verified which showed that it was not working correctly since the clips cannot be placed.It would not load the clip.
 
Manufacturer Narrative
(b)(4).Per the customer provided information the device history review for the alleged instrument was reviewed and found complete without any irregularities.The alleged defective instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc lot in june of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet-kenosha's manufacturing process.This instrument has not been returned for review or evaluation therefore, we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.
 
Event Description
At the time of the preparation of the procedure, the device was opened and its operation verified which showed that it was not working correctly since the clips cannot be placed.It would not load the clip.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key15980119
MDR Text Key308306258
Report Number3011137372-2022-00240
Device Sequence Number1
Product Code GDO
UDI-Device Identifier14026704696816
UDI-Public24026704696813
Combination Product (y/n)N
Reporter Country CodeEC
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915189
Device Catalogue Number544965
Device Lot Number06A2244684
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/07/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED; NONE REPORTED
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