MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR TRANSTAR STAPLER

Catalog Number CS40B

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 03/04/2010

Event Type  Death  

Manufacturer Narrative

(b)(4).Device was not returned for evaluation.Batch # unk.The ees risk manager reached out to the patient's daughter and obtained the following information: the daughter advised her mother's medical history includes a diagnosis of cervical cancer in 1991 and she underwent surgery and chemotherapy.The patient complained of pain after a procedure to treat rectal prolapse in 2010.Subsequent to this procedure, she suffered from many infections.A rectovaginal fistula was diagnosed and repair procedure performed and a colostomy was performed to hopefully alleviate the infections.The contour stapler was used during this procedure with no difficulties.Subsequent to this, problems continued and she underwent exploratory surgery where a vaginal tumor was diagnosed.Subsequently, the tumor was treated with radiation and the patient's condition continued to worsen with infections, exacerbation of rheumatoid arthritis.She was placed on iv antibiotics and treated with hyperbaric oxygen therapy that did not resolve the infections.She ultimately required treatment by hospice until she passed away in (b)(6) 2015.During the course of many years, she was treated by many different physicians; however, according to the daughter, the pain was never resolved.

Event Description

It was reported that during rectal prolapse procedure; it is believed by the patient's daughter that it is possible a circular stapler malfunctioned.Several surgeons stated that they saw and felt mesh or staples.The patient had major pain that she described as a broken bottle inside her, slivers of glass inside her vagina and rectum.She had another rectal prolapse surgery to try again to repair.This time another circular stapler was used, her pain worsened.She later had multiple visits to surgeons, obgyn's and her family doctor.She was told that she had a recto vaginal fistula and had to have a colostomy.Still, there was no pain relief.Later the patient had exploratory surgery done by two surgeons, one went in rectally and the other vaginally.A vaginal tumor was found.Treatments had to be done and were successful as the tumor couldn't be seen or felt, but nothing else was said about what they believed to be staples.These statements are documented and also the location of them, which are nowhere near the location of the tumor.The patient was simply in too much pain to go to any more doctors.After trying numerous medications, hyperbaric oxygen, etc.Was placed with hospice care.She was on fentanyl patches, methadone, and morphine just to name a few of her medications and still complained with the broken bottle, slivers of glass pain inside her rectum and vagina.She passed away 2015.There are no devices available for return.

• Brand Name: CONTOUR TRANSTAR STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5396823
• MDR Text Key: 37035725
• Report Number: 3005075853-2016-00586
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CS40B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death