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

Device Problems Implant, removal of (2320); Implant, repositioning of (2321)

Patient Problems Failure of Implant (1924); Surgical procedure (2357)

Event Date 08/09/2012

Event Type  No Answer Provided  

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.

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.

• Brand Name: FILSHIE TUBAL LIGATION SYSTEM CLIPS
• Type of Device: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL; trumbull CT
• Manufacturer Contact: howard beaumont ; stuart ct, spursholt place; salisbury rd; romsey, hampshire SO51 -6DJ ; UK SO51 6DJ ; 794525100
• MDR Report Key: 2834148
• MDR Text Key: 10401319
• Report Number: 8021955-2012-00001
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 10/29/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2012
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2012
• Date Manufacturer Received: 10/03/2012
• 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