MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number LCSXX

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

Patient Problems Fistula (1862); 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.This complaint has been documented based on the information available within the article; however, due to the publication date of this article, additional event details will not be pursued as in some cases, complaints in articles cannot be reasonably investigated due to the age of the article.

Event Description

It was reported that during review of journal article, title : impact of technological advances on complications of revisional bariatric operations author : robert e brolin, md, facs, ronald p cody.Citation: j am coll surg (2008); 206:1137¿1144.Doi: 10.1016/j.Jamcollsurg.2008.01.011.The goal of this article was to determine the impact of cumulative experience in conjunction with changes in both operative techniques and instrumentation on the outcomes of the procedures.Between june 1983 and august 2005, 215 patients had revisional bariatric operations.The outcomes of these consecutive revisional bariatric were assessed before and after routine use of 6-row endostaplers and harmonic scalpel (ethicon), which began in 2001.Primary operations for these 215 patients who underwent revisions were: 26 patients (3 male and 23 female; age: 49 ± 10 years) underwent jejunoileal bypass; 39 patients (7 male and 32 female; age: 45 ± 8 years) underwent horizontal stapled gastroplasty (gp); 28 patients (5 male and 23 female; age: 43 ± 8 years) underwent vertical banded gastroplasty (vbg); 15 patients (2 male and 13 female; age: 42 ± 10) underwent gastric band; 95 patients (20 male and 75 female; age: 44 ± 5) underwent roux-en-y gastric bypass (rygb); and 12 female patients (age: 45 ± 12) underwent loop gastric bypass.From 1983 to 2000, 139 patients (ta stapler group) used ta staplers for transection of the stomach and between 1991 and 2001, 2/0 vicryl suture (ethicon) was used to oversewn the transected staple line.From 2001 to 2005, 76 patients (endostapler group) used an endostapler and harmonic scalpel (ethicon) for stomach transection and in cases in which tissue quality was questionable, gastric staple lines were oversewn with 2-0 vicryl suture (ethicon).Reported complications in the ta stapler group included gastrointestinal leak (n-?), left upper quadrant abscess with associated fistula (n-?), erosion of retention sutures into the bowel with associated fistula (n-?), perigastrostomy tube leak with associated fistula (n-?), stomal stenosis (n-?) in which 1 patient had an extended hospital stay, acute gastric dilatation (n-?) that was treated by percutaneous gastrostomy, and ischemic necrosis of the gastric pouch (n-?).Death due to sepsis resulting from the ischemic necrosis of the gastric pouch (n-?) reported complications in the endostapler group included gastrointestinal leak (n-2), left upper quadrant abscess with associated fistula (n-?), perigastrostomy tube leak with associated fistula (n-?), and erosion of retention sutures into the bowel with associated fistula (n-?).Incorporating the endostaplers and harmonic scalpel into open revisional operations significantly reduced postoperative complications.The results also suggest that surgeons perform their initial revisions on their own patients rather than on patients who had primary procedures elsewhere.Patients presenting as candidates for a second revision should be cautiously evaluated, anticipating a high morbidity rate.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 9441153
• MDR Text Key: 188172447
• Report Number: 3005075853-2019-24124
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention