MAUDE Adverse Event Report: INTERNAL SURGICAL STAPLE/CLIP; STAPLE, IMPLANTABLE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

I've had 3 laparoscopic surgeries in my lower pelvic / abdominal region.The 1st was in 2001 for an appendectomy, the 2nd for endometriosis and removal of a cyst on my right ovary in 2010, and the 3rd for reoccuring endometriosis and removal of several small subserosal fibroids in 2018.In the laparoscopic surgical photos i received in 2010, there is a picture of an isolated internal surgical staple or clip in one of the pictures, and in another picture from that same surgery, there is a group of surgical staples or clips in an area of my intestine that i believe was the method used to close up the stump of my appendix from my appendectomy in 2001.Another picture of what appears to be the same isolated staple/clip was found during my 2018 laparoscopy, and my surgeon was successfully able to remove it without any complications.Fda safety report id# (b)(4).

• Brand Name: INTERNAL SURGICAL STAPLE/CLIP
• Type of Device: STAPLE, IMPLANTABLE
• MDR Report Key: 8531814
• MDR Text Key: 142739415
• Report Number: MW5086014
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/17/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1