MAUDE Adverse Event Report: ETHICON ENDO SURGERY, INC (CINCINNATI) PROXIMATE CIRCULAR STAPLER; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

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

Patient Problems Sepsis (2067); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The exact event date is unknown.It is presumed to have occurred in 2012 when the article was published.A specific month and day are unknown.Additional information: complaint database was queried to ensure this event has not been previously reported.As the event was reported based on the review of a journal article, attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient with an end-to-end anastomosis developed peri-anastomotic sepsis after the circular anastomotic staple line was reinforced laparoscopically with sutures at a presumed point of weakness.The patient underwent laparotomy on postoperative day 8 and the anastomosis was refashioned.A secondary intraabdominal abscess was drained percutaneously and the patient had finally recovered with no anastomotic stenosis at 6 months.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: no, i don¿t think the leak was related to the stapler, it could have been a technical problem.Of course i cannot exclude a stapler problem, but there had not been any strange dysfunction during the surgery.

• Brand Name: PROXIMATE CIRCULAR STAPLER
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC (CINCINNATI); 4545 creek rd; cincinnati OH 45242 2803
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (TORRES); avenida de las torres 7125 par; que; ciudad juarez, chihuahua ; MX
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6211213
• MDR Text Key: 63475692
• Report Number: 1527736-2016-00050
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2017
• 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): Required Intervention