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

Catalog Number LCSXX

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 01/01/2002

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2002.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.

Event Description

Title: establishing a laparoscopic gastric bypass program.Author : alexandra dresel, m.D.A, joseph a.Kuhn, m.D.A, matthew v.Westmoreland, m.D.A, loraye j.Talaasen, r.N.A, todd m.Mccarty, m.D.Citation: the american journal of surgery 184 (2002) 617¿620.The purpose of this prospective study was to evaluate the outcomes for laparoscopic roux-en-y gastric bypass in a newly developed bariatric surgery program.Between dec 2000 and oct 2001, a total of 100 patients [n=100 (n=90 female, n=10 male, mean age 39 years (range 17¿58 years), mean bmi 49 kg/m2 (range37¿74 kg/m2))] underwent laparoscopic roux-en-y gastric bypass.Pneumoperitoneum was established via a 12-mm optiview trocar (ethicon endo-surgery).The lesser sac was entered using a harmonic scalpel (ethicon endo-surgery) and an opening was created in the transverse mesocolon.The ligament of treitz was identified and the proximal jejunum was divided 20 to 30 cm distal to the ligament using a 45-mm ets45 endoscopic linear stapler (ethicon endo-surgery).The small bowel mesentery was divided with the harmonic scalpel.A side-to-side jejunojejunostomy was created with two sequential fires of the endoscopic linear stapler and the enterotomy was closed in a similar fashion.The anvil of the 21-mm endopath ils endoscopic circular stapler (ethicon endo-surgery) was attached to a clamp and inserted into the abdominal cavity via the assistant¿s 12-mm port site.A gastrotomy was made in the body of the stomach using the harmonic scalpel and the anvil brought into the stomach with a right angle endoscopic grasper.The anvil was positioned inside the proposed pouch and the harmonic scalpel used to make a gastrotomy small enough for only the post of the anvil to exit.The circular stapler was then placed into the abdominal cavity via the assistant¿s port site and inserted into the jejunal limb via a jejunotomy created with the harmonic scalpel.The stapler was opened and attached to the anvil, creating an antegastric, retrocolic roux limb.The stapler was fired, closed, and removed from the body.The gastrotomy and jejunostomy were closed with a linear stapler.The skin incisions were all closed with subcuticular sutures and dermabond (ethicon) was placed on all wounds.Postoperative complications included failure of the harmonic scalpel to function correctly (n=2) which required conversion to open rygb; postoperative gastrointestinal hemorrhage (n=3) which required blood transfusion with resolution of the bleeding within 24 hours and none of these patients required reoperation; leak at the proximal gastric transection line (n=1) requiring operation; leak at the distal gastric transection line, secondary to a jejunonejunostomy obstruction (n=1) requiring operation; nasogastric tube had been transected (n=1) which required reexploration; malfunction of the linear stapler (n=1) which required conversion to open rygb; anastomotic leak from a linear staple line (n=1) requiring operation; anastomotic strictures at the gastrojejunostomy (n=3) which was successfully endoscopically dilated; superficial wound infections (n=2); and port site hernia (n=1) that was repaired primarily without difficulty as an outpatient.Laparoscopic roux-en-y gastric bypass is a technically challenging procedure that can be safely integrated into a bariatric treatment program with good results.Improved outcomes, shorter operative times, and fewer complications are associated with increased surgical experience.

• 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: 9382975
• MDR Text Key: 168772136
• Report Number: 3005075853-2019-23835
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention