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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, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
When the user attempted to ligate a clip during a surgery, he/she did not hear the usual clicking sound and felt something different.He/she removed the applier from the patient and tested to ligate then some clips were not locked properly.He/she replaced the applier with another one by which was able to ligate and complete the surgery.The applier was purchased by the hospital within 6 months.
 
Event Description
When the user attempted to ligate a clip during a surgery, he/she did not hear the usual clicking sound and felt something different.He/she removed the applier from the patient and tested to ligate then some clips were not locked properly.He/she replaced the applier with another one by which was able to ligate and complete the surgery.The applier was purchased by the hospital within 6 months.
 
Manufacturer Narrative
(b)(4).The ohr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50-piece lot in march of 2020.Evaluation of the returned device as received shows that the jaws are slightly loose and misaligned to each other in the closed position and it has a non-teleflex luer flush fort cap installed on the luer flush port.We are able to validate this complaint since the jaws are not aligned in the closed position and that could make it difficult to close a clip.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (n00185) bosses are both damaged where they engage the jaws.(pie's attached) we suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod bosses to ecome damaged but mishandling of this device at the end user's facility 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 omplaint and this record will be deemed closed.
 
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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
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key12569016
MDR Text Key274515604
Report Number3011137372-2021-00259
Device Sequence Number1
Product Code GDO
UDI-Device Identifier24026704696813
UDI-Public24026704696813
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
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 Number06F1989611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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