MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CLIP - EXACT CODE UNKNOWN; CLIP, IMPLANTABLE

Catalog Number CLIPXX

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

Patient Problems Abscess (1690); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information: additional information requested from author: does the surgeon believe that ethicon ligaclip appliers caused or contributed to the patient complications mentioned in this journal article? if yes, please explain.To date no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during review of a journal article, title: pure laparoscopic liver resection reduces surgical site infections and hospital stay.Results of a case-matched control study in 50 patients author : santiago lópez-ben & oscar palacios & antonio codina-barreras & m.Teresa albiol & laia falgueras & ernesto castro & joan figueras.Citation: langenbecks arch surg (2014) 399:307¿314; doi 10.1007/s00423-014-1169-7.The aim of this case-matched control study is to analyze the short-term outcomes of patients who underwent laparoscopic liver surgery, most of them with malignant tumors, compared with the open approach, performed in a single center, by the same surgical team and in the same period of time.Between may 2005 and october 2012, we performed 50 consecutive laparoscopic (lap) liver resections (in 49 patients) (n=35 male n=15 female, mean age of 64 years, range 33-86, mean bmi 26 kg/m2).This was compared with 98 patients (100 procedures) (n=63 male n=37 female, mean age of 62 years, range 31-85, mean bmi 27 kg/m2) operated by open (op) approach that were matched 2 to 1 with 49 lap patients (50 procedures).In lap group, liver dissection and transection were performed combining cavitational ultrasonic surgical aspirator (cusa), the harmonic ace 36 (ethicon), and/or dolphin tip laparoscopic ligasure sealer/divider.The medium sized vessels were sealed with plastic (hemo-lock) or metal clips (ligaclip, ethicon).In op group, parenchymal transection is commonly performed by a combination of cusa and harmonic focus long curved shears (ethicon).In both groups, echelon flex 60 endopath stapler (ethicon) or endo gia (covidien) with white cartridge was used for major vascular pedicle sealing.Complications included blood loss of 401ml [18-2192ml] in lap group (n=50), blood loss of 475ml [20-2000ml] in op group (n=100).In one patient (from op group who had lap conversion), packing was necessary due to persistent oozing from the raw surface.Other complications were biliary fistula (n=3 op group), hemoperitoneum (n=4 lap group, n=4 op group), intraabdominal abscess (n=1 lap group, n=12 op group), ascites (n=4 lap group, n=4 op group), and readmissions (n=7 op group).The data in the study demonstrates that the laparoscopic technique in hepatectomy has better results in terms of postoperative morbidity, mainly infective, hospital stay and readmission.

• Brand Name: CLIP - EXACT CODE UNKNOWN
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9359840
• MDR Text Key: 181935545
• Report Number: 3005075853-2019-23679
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLIPXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention