MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE CIRCULAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number CDH33A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Tissue Damage (2104); No Code Available (3191)

Event Date 03/16/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) date sent: 4/7/2016 information was not provided by the contact.Information is unavailable; device was not returned for evaluation.Batch # unk.Additional information was requested and the following was obtained: what were the indications for surgery? st follow all indications during the procedure related to the device.She was present during the whole procedure.Tumor colon did the patient receive any chemotherapy or radiation prior to the surgery? according to what surgeon said, patient hadn¿t received any chemotherapy.Regarding the first device: who fired the device and what is his/her experience? the surgeon dr.Barrios fired the device, he didn¿t experience nothing wrong with it.Where within the green range was the device fired? not exactly as it is not easy to see.But it was thick tissue between 2,2 mm to 2,5 mm.Was there any audible or tactile feedback? surgical tech didn¿t receive the audible feedback.Were the washers inspected? if so, please describe.It was inspected, it was broken.Were the donuts inspected? if so, please describe.They were inspected and surgeon did not find nothing wrong, both were complete.Were there any issues with staple formation? if so, please describe.There was no clear evidence for the staple formation.What were the indications for the second surgery and how was it diagnosed? patient was not feeling good and was taken for a diagnostic laparoscopy, cavity was fully contaminated.Was a leak test performed? after the use from the first device, the leak test was perform, but there was no clear evidence that it was well done.What is meant by ¿tissue was damaged¿ and ¿anastomosis not well completed¿? as the cavity was contaminated because of the fistula, most of the tissue from patients rectum and large intestine was damaged, there was no healthy tissue to complete a good anastomosis.Regarding the 2nd device: who fired the device and what is his/her experience? the surgeon.When it was fired there was an audible feedback, although he knew tissue was in really bad shape.Where within the green range was the device fired? not exactly as it is not easy to see.But it was thick tissue between 2,2 mm to 2,5 mm was there any audible or tactile feedback? there was an audible feedback.Were the washers inspected? if so, please describe.It was inspected, it was broken.Were the donuts inspected? if so, please describe.For the second device, proximal donut look very good, but distal donut didn¿t look symmetric, there was a piece of tissue attached to the donut that of almost 6 mm.Were there any issues with staple formation? if so, please describe.No information available.How long after surgery did the patient die? 36 hours later.What was the cause of the patient¿s death? we don¿t have access to this information was an autopsy performed? if so, could you provide a copy? we have information that there was not an autopsy authorized, although surgeon is the one that authorizes.Is the surgeon willing to speak with the cross functional team including the medical safety officer and engineering? he will but with someone who knows about product and the procedure.

Event Description

It was reported that during a laparoscopic left hemicolectomy procedure, when the circular stapler was fired for the anastomosis between the rectum and the large intestine, there was no feedback sound from the broken plastic.Surgical tech advice to make a leak test, but there was no clear evidence of any leakage.Surgical tech was on the procedure from the beginning to the end.The patient was reintervened via laparotomy procedure, and surgeon found the cavity fully contaminated.Patient was cleaned, used a curved cutter stapler with green reload to remove another piece, took a second device, having this time an audible feedback for the complete stapling.Unfortunately tissue was already damaged and anastomosis was not well completed.Surgeon has not confirmed yet that the first use of device was responsible for the complication.One device was discarded.

• Brand Name: PROXIMATE CIRCULAR STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• 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: 5555043
• MDR Text Key: 42089446
• Report Number: 3005075853-2016-01924
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDH33A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• 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
• Patient Age: 64 YR