MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL HANDPIECES (EXACT CODE UNKNOWN); ULTRASONIC SURGICAL SYSTEM HANDPIECE, HAND-CONTROLLED, REUSABLE

Catalog Number HPXXX

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Hernia (2240); Peritonitis (2252); Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.Batch # unk.(b)(4).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.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: natural orifice specimen extraction for colorectal surgery: early adoption in a western population authors: michelle zhiyun chen, john cartmill, andrew gilmore citation: colorectal disease (2021);23:937943.Doi: 10.1111/codi.15455.The aim of this retrospective study of a prospectively collected data is to demonstrate the feasibility of nose colectomy in an (b)(6) population.From 2007 to the present, a total of 159 patients (61 male and 98 female; mean age of 59 years (1988); mean bmi of 28.2 (1745) kg/m2) with benign colorectal conditions such as complicated diverticular disease, post malignant polypectomy and volvulus who underwent natural orifice specimen extraction (nose) colectomy, were included in the study.Surgery was performed using a harmonic scalpel (ethicon), 0-prolene purse string (ethicon), ethibond suture (ethicon), and pds endoloop (ethicon).Reported complications included retroperitoneal small bowel herniation (n=10) which required further surgery in 7 patients, ileus (n=7), postoperative pelvic bleeding (n=2), small bowel injury (n=1), pseudo-obstruction (n=1), abdominal wall swelling (n=1), clostridium difficile colitis (n=3), and peritonitis (n=1).In conclusion, this large series of nose colectomy from australia suggests that nose is comparable to conventional laparoscopic colectomy in terms of postoperative outcome.Given that obesity has not featured in the nose literature, our study suggests that nose, for benign disease, is safe in obese patients, without added morbidity.

• Brand Name: HARMONIC SCALPEL HANDPIECES (EXACT CODE UNKNOWN)
• Type of Device: ULTRASONIC SURGICAL SYSTEM HANDPIECE, HAND-CONTROLLED, REUSABLE
• 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 ; * ; 6107428552
• MDR Report Key: 12474197
• MDR Text Key: 271471288
• Report Number: 3005075853-2021-05473
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: LFL
• 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: 08/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention