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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
Catalog Number 544965
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
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
The jaws of the applier did not open after ligation during a thoracic surgery.The user ligated the both ends of the vascular with another applier, then completed the treatment with a harmonic scalpel.No harm to the patient was reported.The applier was purchased by the hospital in march.
 
Manufacturer Narrative
Qn# (b)(4).The dhr 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 pc.Lot in (b)(6) 2020.Evaluation of the returned instrument shows that the knob rotation and handle to jaw mechanisms are dry and sluggish feeling and in need of proper lubrication.Further evaluation shows that the open jaw gap measures to print specifications of.280 +/-.025 at.267.Functional testing shows that this instrument is 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 validate this complaint since we were unable to replicate the alleged issue.After the initial evaluation this instrument was properly lubricated using non-silicone based instrument lube as it was prior to shipment to the customer and as recommended in ifu (b)(4) which was supplied with the instrument when it was produced and the knob rotation and handle to jaw mechanisms were 100% visually inspected and function tested and lubricated 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
The jaws of the applier did not open after ligation during a thoracic surgery.The user ligated the both ends of the vascular with another applier, then completed the treatment with a harmonic scalpel.No harm to the patient was reported.The applier was purchased by the hospital in march.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11844558
MDR Text Key251703282
Report Number3011137372-2021-00148
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06F1989611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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