MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number XCEL

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

Patient Problems Failure to Anastomose (1028); Anemia (1706); Hematoma (1884); Pain (1994); Seroma (2069); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Event date unk.Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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.Does the surgeon/author believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.(b)(4).

Event Description

It was reported via journal article title: randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (iea trial) authors: j.Bollo, v.Turrado, a.Rabal1, e.Carrillo, i.Gich, m.C.Martinez, p.Hernandez and e targarona.Citation: bjs 2020; 107: 364¿372.Doi: 10.1002/bjs.11389.The aim of this rct was to compare the two surgical techniques, and to define the possible benefits of ia versus ea in patients undergoing elective right colectomy.This randomized, single-blind and single-centre clinical trial, the intracorporeal versus extracorporeal anastomosis (iea) study involves 139 patients who were referred for treatment of a right colonic adenocarcinoma from may 2015 to june 2018.Sixty-nine patients (34 male and 35 female; mean age (sd): 72.7 (10.4) years; age range: 45-89 years; bmi: 27.4(5.4) kg/m2) were included in the intracorporeal anastomosis group, and 70 patients (39 male and 31 female; mean age (sd): 70.9(11.7) years; age range: 28-90 years; bmi: 26.3 (4.7) kg/m2) were included in the extracorporeal anastomosis group.During the procedure, the first trocar, endopath® xcel¿ with optiview¿ (ethicon, tampa, florida, usa), was inserted in the left iliac fossa to create the pneumoperitoneum, and an exploratory laparoscopy undertaken.A second trocar was placed at the right iliac fossa and another in the suprapubic region to act as working ports.A fourth trocar was positioned in the left subcostal flank for assistance.If intracorporeal anastomosis (ia) was designated, dissection of the mesocolon was completed, and the ileum and transverse colon were transected using an endo-gia stapler (echelon flex¿, 60 mm, blue cartridge; ethicon).A side-to-side antiperistaltic ileocolic anastomosis was created with the endo-gia stapler (echelon flex¿, 60 mm, blue cartridge; ethicon) and the enterotomy was closed with two running sutures of prolene® 2/0 (ethicon).If extracorporeal anastomosis (ea) was designated, a transverse incision was made.The ileum and colon were extracted, and dissection of the mesocolon completed.A side-to-side antiperistaltic anastomosis was created with a gia stapler (proximate®75 mm, blue cartridge; ethicon) and the two bowel ends were closed with a ta stapler (proximate® tx 90 mm; ethicon).Reported complications in intracorporeal anastomosis group included mean (sd) postoperative pain score of 2.73(2.32) at day 1 (n-?), mean (sd) postoperative pain score of 1.81(1.85) at day 2 (n-?), mean (sd) postoperative pain score of 2.06(2.19) at day 3 (n-?), mean (sd) postoperative pain score of 1.72(1.91) at day 4 (n-?), mean (sd) postoperative pain score of 1.71(2.18) at day 5 (n-?), mean (sd) decrease in haemoglobin level of 8.8 (1.7) (n-?) in which 5 patients had a red blood cell transfusion, grade i paralytic ileus (n-4), grade i wound seroma (n-3), grade ii paralytic ileus (n-5) and parenteral nutrition, anaemia (n-3) in which the patient had a rbc transfusion, grade ii lower gastrointestinal bleeding (n-2) with rbc transfusion, grade ii wound infection (n-3), grade ii anastomotic leak (n-3) in which 2 were treated with antibiotic treatment and 1 with surgical reoperation.In extracorporeal anastomosis group included mean (sd) postoperative pain score of 3.01(2.29) at day 1 (n-?), mean (sd) postoperative pain score of 2.91(2.25) at day 2 (n-?), mean (sd) postoperative pain score of 2.36(2.12) at day 3 (n-?), mean (sd) postoperative pain score of 2.49(2.23) at day 4 (n-?), mean (sd) postoperative pain score of 2.42(1.93) at day 5 (n-?), mean (sd) decrease in haemoglobin level of 17.1 (1.7) (n-?) in which 9 patients had a red blood cell transfusion, grade i paralytic ileus (n-10), grade i wound seroma (n-3), lower gastrointestinal bleeding (n-1) in which the patient had a reoperation, grade i lower gastrointestinal bleeding (n-6), grade ii paralytic ileus (n-11) and parenteral nutrition, anaemia (n-5) in which the patient had a rbc transfusion, grade ii lower gastrointestinal bleeding (n-3) in which the patient had a rbc transfusion, grade ii wound infection (n-3), garde ii colitis (n-1), grade ii anastomotic leak (n-5) in which 3 were treated with antibiotic treatment, 1 with radiological drainage and 1 with surgical reoperation, ileal ischaemia (n-1) in which the patient had a reoperation, and intra-abdominal haematoma (n-1) in which the patient had a reoperation.In conclusion, duration of hospital stay was similar, but ia was associated with less pain and fewer complications.

• Brand Name: ENDOPATH XCEL TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10279120
• MDR Text Key: 200831245
• Report Number: 3005075853-2020-03578
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XCEL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention