|
Catalog Number 22-4038 |
Device Problem
Break (1069)
|
Patient Problem
No Information (3190)
|
Event Date 07/09/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that when using the device during a shoulder surgery, the retractable needle did not retract when it was located at the shoulder cuff.The surgeon was able to remove the medical device carefully without severing the shoulder cuff.The procedure was completed with the same device.It is unknown if there was a delay in the case.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Event Description
|
It was reported that when using the device during a shoulder surgery, the retractable needle did not retract when it was located at the shoulder cuff.The surgeon was able to remove the medical device carefully without severing the shoulder cuff across the surgical approach.However, besides the needle perforation, there was damage to subcutaneous and muscle non-target tissues.The procedure was completed with the same device and no significant delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
H10.Additional information in b5.
|
|
Manufacturer Narrative
|
The reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: -as with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.- do not use this device as a lever for manipulating hard tissue or bone.Excessive force should not be applied to the device when manipulating soft tissue, bone, or hard objects.Misuse of this device may result in bent or broken distal tip or jaws.- when passing suture multiple times always check the tip of the device for damage or debris between passes.Clear any visible debris between passes.Discontinue use if the device becomes damaged between passes.-tissue thickness may affect suture placement including stitch depth and needle entry point.-ensure adequate visibility when using the device.Should the needle tip become lodged (e.G., in bone), the needle should be disengaged by retracting it into the suture passer.Twisting or bending of the needle to dislodge the needle tip may result in breakage of the needle and needle parts may not be retrievable.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with a closed top bracket which could not be opened; the needle is bent.The first step of the trigger is stuck; releasing is not possible; the device was dissected and a jam was indicated; a bent pin was found ; further tests were not possible due to the damage.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
|
|
Search Alerts/Recalls
|
|
|