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

Catalog Number ECS29A

Device Problems Device Or Device Fragments Location Unknown (2590); Difficult to Advance (2920)

Patient Problems Death (1802); No Code Available (3191)

Event Date 05/08/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent: 05/25/2016.Additional information was requested and the following was obtained: where within the green range was the device fired? the stapler was fired within the maximum range.What healthcare worker fired the device and what is his/her experience in positioning and firing the device? assistant surgeon with good surgical experience.Was the washer inspected? if so, please describe.Hydropneumatic test was performed successfully (blowing air into the rectum and pelvis with water under direct vision from suprapubic access service).When was the anastomosis performed in relation to the patient¿s hospitalization for diverticulitis? in the same day: hospitalization for acute diverticulitis, inflammatory pseudotumor, diverticulum perforated and buffered (hinchey 2).What is the current patient status? the patient died after 10 days in intensive care due to posthumous sepsis due to peritonitis stercoraceous.

Event Description

It was reported that after a left colon diverticulitis procedure, the patient was hospitalized in emergency due to a diverticulitis.During the trans anal anastomosis, due to the presence of a lot of tissue, the surgeon experience difficulty in moving the orange band, reach for which the device was pushed forward and backward twice.Once appeared the orange band, the head was connected to the trocar.At the time of firing, no auditive feedback was heard, but the check of tissues' rings and the pneumatic trial had a positive result.After the intervention, (3 hours later) the patient felt bad and was necessary and emergency revision because the abdomen was still full of feces.The anastomosis failed and no clip was found in the abdomen.The surgeon did a manual anastomosis.The patient is in intensive care unit.One device was discarded.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: was the washer inspected, if so, please describe: the washer has been inspected and the system was uncut; in the additional information, it was noted the device was fired within the maximum range.Is this the high b setting or low b setting: the stapler was closed in the maximum range (maximum green).

• 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: 5679728
• MDR Text Key: 45956370
• Report Number: 3005075853-2016-02981
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K940967
• 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,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECS29A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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