Model Number IPN915189 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/08/2022 |
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
|
It was reported that jaws of the applier were found broken when the user tried to ligate the cystic duct during the procedure.No fragments were fell/remained in the patient.Because of the applier condition, the user thought the applier could not be removed from a trocar, so it was removed together with the trocar.A new trocar and an applier were used to complete the procedure.There was no patient injury reported as a result of this issue.
|
|
Manufacturer Narrative
|
(b)(4).The device history review for the returned device was reviewed and found complete without any irregularities.This device was produced at the tecomet, inc.Kenosha wi facility as part of a 50-pc.Lot in march 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 returned device as received shows that the jaws are bent to the right and loose and misaligned to each other in the closed position and the jaw pivot pin is pulled through one side of the bent/damaged outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was did-assembled in order to evaluate its internal components and it was found that the inner drive rod is bent where it engages that jaws and its bosses are also both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned.We are unable to determine what caused the jaws to be bent to the right and for the drive rod and its bosses to be damaged and for the jaw pivot pin to be pulled through on side of the bent/damaged outer tube assembly 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 tis facility for this product line.Due to these findings, no further actions will be taken in response to tis complaint and this record will be deemed closed.
|
|
Event Description
|
It was reported that jaws of the applier were found broken when the user tried to ligate the cystic duct during the procedure.No fragments were fell/remained in the patient.Because of the applier condition, the user thought the applier could not be removed from a trocar, so it was removed together with the trocar.A new trocar and an applier were used to complete the procedure.There was no patient injury reported as a result of this issue.
|
|
Search Alerts/Recalls
|