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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE TUBAL LIGATION SYSTEM CLIPS FILSHIE CLIPS

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COOPER SURGICAL FILSHIE TUBAL LIGATION SYSTEM CLIPS FILSHIE CLIPS Back to Search Results
Device Problems Implant, removal of; Implant, repositioning of
Event Date 08/09/2012
Event Type  No Answer Provided  
Event Description

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.

 
Manufacturer Narrative

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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Brand NameFILSHIE TUBAL LIGATION SYSTEM CLIPS
Type of DeviceFILSHIE CLIPS
Manufacturer (Section D)
COOPER SURGICAL
trumbull CT
Manufacturer Contact
howard beaumont
stuart ct, spursholt place
salisbury rd
romsey, hampshire  SO51 -6DJ
  SO51 6DJ
794525100
MDR Report Key2834148
Report Number8021955-2012-00001
Device Sequence Number1
Product CodeKNH
Report Source Manufacturer
Source Type Distributor
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/14/2012
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/09/2012
Event Location Hospital
Date Report TO Manufacturer09/14/2012
Date Manufacturer Received10/03/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 10/29/2012 Patient Sequence Number: 1
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