Device Problems
Implant, removal of (2320); Implant, repositioning of (2321)
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Patient Problems
Failure of Implant (1924); Surgical procedure (2357)
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Event Date 08/09/2012 |
Event Type
No Answer Provided
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Manufacturer Narrative
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The mfr of the device is femcare (b)(4), not (b)(4) (as listed by the initial reporter).
Femcare-(b)(4) is filing this report because a health care professional has indicated an adverse event.
Filshie clips commonly cause tissue necrosis and sometimes migrate away.
As there is no evidence of a complication related to the clip, femcare-(b)(4) disagrees that this was an adverse event.
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Event Description
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Pt had same day surgery on (b)(6) 2012 for "operative laparoscopy with proximal salpingectomy, lysis of adhesions, removal of bilateral filshie clips and coagulation of suspected endometriosis.
The pt presented with pelvic pain and it was reported to be going on for about a yr.
The surgery revealed ovaries normal limits, uterus and anterior fundal fibroid.
Some dilation of proximal left fallopian tube.
Filshie clip was completely disconnected from the tube and adhered in the mesosalpinx and to the cornul region of the uterus.
Tubes separated bilaterally and filshie clip was not attached to the right fallopian tube as well which was just sitting in the mesosalpinx.
The filshie clip on left was grasped during the procedure.
Adhesions were lysed sharply after elevation with lap scissors.
The device delivered through the umbilical port.
Filshie clip was hanging in the mesosalpinx on the right hand site.
Grasped again and excised with delivery also through umbilical port.
Hemostasis noted and pt recovered and discharged home.
No more info available on age of filshie clips.
Unable to determine when device placed.
Not done at this facility.
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Search Alerts/Recalls
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