MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 75MM SELECTABLE NEW TLC; STAPLE, IMPLANTABLE

Catalog Number NTLC75

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199); Peritonitis (2252); No Code Available (3191)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.What color setting was device set at for the firings? was there any difficulty firing the device? were there any staple malformation issues identified throughout patient care? how was the common channel of the anastomosis closed (ntlc, another stapling device, or suture)? did the patient undergo any preoperative chemotherapy or radiation? what kind of evaluations were done when that patient came to the emergency room and icu to evaluate the status of the patient? what was the reason that the surgery was performed two days after the readmission to icu? will an autopsy be performed? if so, can a copy of the autopsy report be provided? has the cause of death been identified? would the surgeon be interested in speaking with ethicon medical and engineering personnel regarding this event? translation is available.

Event Description

It was reported that during a right hemicolectomy, there were patient complications due to the use of the device.Patient was operated on for colon cancer on wednesday, (b)(6) 2018, being discharged within the stipulated period for a surgery of this nature.On wednesday (b)(6), he entered the emergency department with hemodynamic deterioration and undergoing an infectious process.After his compensation in icu, surgeon decided to intervene on friday, (b)(6), evidencing a fecaloid peritonitis, apparently caused by a failure of the linear suture of the device used in the colon resection, the most affected area being the proximal transverse edge, having to program multiple posterior surgical procedures.On (b)(6), the sales rep was informed the patient died.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: what color setting was device set at for the firings? light blue.Was there any difficulty firing the device? no.Were there any staple malformation issues identified throughout patient care? no.How was the common channel of the anastomosis closed (ntlc, another stapling device, or suture)? suture.Did the patient undergo any preoperative chemotherapy or radiation? no.What kind of evaluations were done when that patient came to the emergency room and icu to evaluate the status of the patient? in emergency room hematologic tests, biochemistry tests, urinary tests and c-reactive protein tests.In the icu the same tests plus abdominal eco-tomography.What was the reason that the surgery was performed two days after the readmission to icu? initially a surgical observation was planned due to important metabolic decompensation and pre-renal failure that was fixed.Will an autopsy be performed? if so, can a copy of the autopsy report be provided? no autopsy was performed.Has the cause of death been identified? sepsis with abdominal focus and multiple organic failure.Would the surgeon be interested in speaking with ethicon medical and engineering personnel regarding this event? yes.Is the device available for evaluation? no.A call was scheduled, however, the surgeon did not join.Attempts are being made to reschedule the call or determine if the surgeon is no longer interested in speaking with ethicon medical and engineering personnel.

Manufacturer Narrative

(b)(4).Photo evaluation: medical assessment of photos by ethicon medical safety officer: there is an opening on the left-hand side of the staple line.It is not possible to say from the resolution where the beginning of the staple line begins.The intestine is discolored around the hole which would be consistent with intestinal leakage.There is a portion of the small intestine proximal to the hole which appears darker and thicker that the other sections of small intestine consistent with possible intestinal ischemia.There is another photo which shows a through and through hole with forceps in the 2 openings.The bridge of tissue in between both holes is thin and appears ischemic.The right hand side hole appears lateral to the staple line.A call was held with the surgeon and ethicon personnel.Translation provided by regional medical safety officer during the call.Did you experience any issues with the device throughout the care of the patient? dr.Does not feel that there has been a failure from the staples; felt staples were very good in place in the primary procedure.He feels the issue was around the staples in the proximal end.The anastomosis was between the transverse colon and ileum.Upon reoperation, the opening was around the staples.Were there any ischemic conditions? yes, it was ischemic in the proximal end of the stapling.Staple form was good, but the gut was open although the staples were formed.There was one staple opened at the proximal end of the staple line.It was like some internal pressure in the colon would open the staple.Just to confirm, were the staples open? one staple was open on the proximal side; gut was open although the staples were formed.Photos are available and will be sent.What does dr.Believe was the cause of the leak? dr.Thinks it was a mix of issues; hypoproteinemia due to the cancer and an ischemic zone surrounding the staples.The patient¿s tissue seemed good and not friable.Do you have any questions for the engineering team? no.He thinks the stapler is excellent and is the best in the market.He thinks it was something that happened with no fault from the product, the company, himself or hospital.It is something that unfortunately happens.He is very happy with the products.Further information provided: dr.Don¿t think that the ntlc75 device caused the death.He thinks that the opening was because ischemia of the tissue and mainly because a hypoproteinemia of the patient due to the cancer condition.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a death and is being considered a malfunction.

• Brand Name: 75MM SELECTABLE NEW TLC
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7468759
• MDR Text Key: 106777974
• Report Number: 3005075853-2018-09368
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036002625
• UDI-Public: 20705036002625
• Combination Product (y/n): N
• PMA/PMN Number: K092577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: NTLC75
• Device Lot Number: P4T025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 09/25/2018
• Supplement Dates FDA Received: 09/14/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death