MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*ENDO ARTICU LIN CUTTER WHI; STAPLE, IMPLANTABLE

Catalog Number	ATW35
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event date unk.Batch # unk.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.
Event or Problem Description
It was reported via journal article title: usefulness of vessel-sealing devices combined with crush clamping method for hepatectomy: a retrospective cohort study authors: atsushi nanashima, takafumi abo, junichi arai, katsunori takagi, hirofumi matsumoto, hiroaki takeshita, tomoshi tsuchiya, takeshi nagayasu citation: international journal of surgery 11 (2013) 891-897.Doi: http://dx.Doi.Org/10.1016/j.Ijsu.2013.07.012.The aim of this retrospective study was to evaluate the efficacy of the vessel-sealing devices for controlling blood loss, transection time and postoperative complications in hepatectomy as a cohort study.This retrospective study involves 267 patients with liver disease who underwent hepatic resection between 2005 and september 2012.One hundred eighteen patients underwent the conventional crush clamping method between 2004 and 2008 (control group) and 149 patients used vessel sealing devices between 2008 and 2012 (vs group).Of the 149 patients in the vs group, 120 patients (80 male and 40 female) used ligasure devices and 29 patients (20 male and 9 female) used harmonic focus (ethicon)(n-24; 15 male and 9 female) or harmonic ace(ethicon) (n-5; 5 male; mean age 58±9 years).In the case of open laparotomy, larger vessels were tied using absorbable braid (ethicon).Glissonian branches near the secondary trunk were also tied.The isolated large hepatic vein was ligated by endopath-endocutter ets-frex 35 (staple load; 3.0x35 mm, white cartilage; ethicon).The harmonic focus curved shears (ultrasonic coagulator dissector; ethicon) was used for open laparotomy and in limited resection, segmentectomy or sectionectomy and in hemihepatectomy or more extended hepatectomy.A harmonic device generator 300 system (ethicon) was operated using a hand switch (ethicon), as a fullfeatured high-frequency mechanical energy system.Any bleeding site and macroscopically detected bile leakage points in the cut plane were sutured using absorbable 4-0 monofilament polydioxanone (pds)-ii suture (ethicon).Reported complications in the ligasure group during limited resection, segmentectomy or sectionectomy included blood loss (703±619/560±474) (n-?) in which 5 patients received red cell transfusion, hepatectomy-related complications ¿ (n-?), bile leakage (n-1) which was sutured using absorbable 4-0 monofilament polydioxanone suture, and intraabdominal abscess formation (n-2).Reported complications in the ligasure group during hemihepatectomy or more extended hepatectomy included blood loss (1029±637/952±567) (n-?) in which 11 patients received red cell transfusion, hepatectomy-related complications ¿ (n-?), bile leakage (n-2) which was sutured using absorbable 4-0 monofilament polydioxanone suture, and intraabdominal abscess formation (n-3).Reported complications in the harmonic group during limited resection, segmentectomy or sectionectomy included blood loss (534±445) (n-?), bile leakage (n-1) which was sutured using absorbable 4-0 monofilament polydioxanone suture.Reported complications in the harmonic group during hemihepatectomy or more extended hepatectomy included blood loss (1410±1010) (n-?) in which 4 patients received red cell transfusion hepatectomy-related complications ¿ (n-?), uncontrolled ascites (n-8), bile leakage (n-4) which was sutured using absorbable 4-0 monofilament polydioxanone suture, and intraabdominal abscess formation (n-3).In conclusion, the latest vessel sealer is very useful for open and laparoscopic hepatectomy for hepatic parenchymal transection in comparison with the conventional procedure, due to the minimization of blood loss and the shortening of transection time, resulting in better postoperative outcomes in hepatectomy.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9368802
• Report Number: 3005075853-2019-23743
• Device Sequence Number: 3043367
• Product Code: GDW
• UDI-Device Identifier: 10705036012320
• UDI-Public: 10705036012320
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ATW35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention