Catalog Number LX207 |
Device Problems
Peeled/Delaminated (1454); Failure to Form Staple (2579)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: did the peeled handle coating actually puncture or "drill¿ the surgical gloves? or did the peeled handles just have the potential to puncture or "drill" the surgical gloves? was there an actual adverse consequence for the patient (a change to procedure or post-op patient care) as you reported "yes¿ for the question "is it a potential adverse event?" in field 1035 on md&d complaint form? if there was an actual adverse consequence, please describe in detail the adverse consequence that occurred.
|
|
Event Description
|
It was reported that during a myocardial revascularization - cardiac surgery in the dissection of the mammary artery procedure, the clipper is misaligned, forming a cross clip, detaching from the artery.The white handle is peeling and it can drill the surgical gloves.The surgical staff informed the clipper arrives from sterilization center with problem.Suture was used to repair.There were no adverse consequences for the patient.
|
|
Manufacturer Narrative
|
(b)(4).The analysis results found that the lx207 device was received with the handle coating damaged and jaws were misaligned; therefore, the clips could not be loaded into the jaws.However, it could not be determined what may have caused this condition.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history records were reviewed and created by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
|
|
Search Alerts/Recalls
|