MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

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

Patient Problems Sepsis (2067); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/30/2020.Date of event: publication year of 2019.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.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 is the specific number of patients who had intra-abdominal sepsis with the use of ethicon device (harmonic scalpel) ? does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

Title : laparoscopic hand-assisted adrenalectomy for tumours larger than 5 cm author: jennifer buxton, shen h.Vun, david van dellen, richard wadsworth, titus augustine.Citation: clinical endocrinology.2019;90:74¿78; doi: 10.1111/cen.13883.This retrospective study aimed to assess the efficacy of hand-assisted laparoscopic (hal) for patients requiring adrenalectomy for tumours over 5 cm in size.From october 2006 ¿ may 2015, a total of 56 patients were enrolled in the study.During the procedure, on the left side, the hand is used to retract the splenic flexure of the colon and the spleen during dissection with the harmonic scalpel (ethicon) or ligasure.Once the splenic flexure and the spleen are mobilized, the intra-abdominal hand is positioned so that there is a working space within the palm and fingers in which dissection can be safely carried out at the same time digitally identifying the adrenal lesion, defining margins and assisting in the dissection.Reported complication included persistent bleeding (n=1) which was intra-operatively converted to open surgery; intra-abdominal sepsis (n=?) which were successfully treated with antibiotics and did not require further surgical intervention.In conclusion, hand-assisted laparoscopic surgery offers a safe reproducible approach to adrenal surgery combining minimally invasive surgery with tactile integration.Hal is a safe minimally invasive surgical option for larger tumours, including malignancies.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 9649413
• MDR Text Key: 190517349
• Report Number: 3005075853-2020-00624
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention