|
Model Number UNKNOWN |
Device Problem
Failure to Obtain Sample (2533)
|
Patient Problem
Blood Loss (2597)
|
Event Date 11/24/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
1.We originally talked to (b)(6) who was listed on the report.She referred us to (b)(6), who originally said they would return the clamp for evaluation.We then tried to contact the hospital many times with no response.We finally got a response , which, said they will not be returning the clamp because it was involved in an incident.2.We requested pictures which they also said they could not provide.3.Therefore, we cannot determine the following: a.If the clamp was manufactured by allied hpi b.The age and or how often the clamp was used.C.Condition of the clamp.4.The part number listed on the report is not ours.5.Their report said the clamp was disposable.Our clamp is re-usable.6.This incident was not directly reported to us.We learned of this incident from the fda.7.We do not know if this is a genuine gomco clamp or a copy made by another manufacturer.8.It does not appear that they followed the instructions, which are sent with each allied clamp.Which state: warning: a.This clamp must never be used if component parts are damaged, missing, clearly worn, or the assembled device does not perform as described.B.Prior to initiating the surgical procedure, you must insure that expected clamping function has been properly achieved.C.Important: some bleeding may occur and or some sutures may be required depending on the prescribed surgical technique.
|
|
Event Description
|
It ws reported that a circumcision procedure performed by a physician, a 1.3 gomco was used.When it was time to tighten the clamp, the physician was unable to completely tighten the nut on the threaded post.When physician turned the nut, it would spin around, but, would not move down the threads to tighten the clamp.Due to the inability to completely tighten the clamp during the procedure, additional pressure and silver nitrate were applied by the physician to stop the oozing.After the procedure was completed, the gomco clamp was removed and inspected.A small defect was noted on the threads about midway down the post.
|
|
Search Alerts/Recalls
|
|
|