MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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.Date of event is unknown.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during review of a journal article: title: laparoscopic surgery.Combined with preservation of the spleen for distal pancreatic tumors.Author(s): a.Vezakis, d.Davides, m.Larvin, m.J.Mcmahon.Citation: surg endosc (1999) 13: 26¿29.The purpose of this study is to present the initial experience with laparoscopic resection of distal pancreatic tumors, combined with preservation of the spleen.Between nov 1993 and jun 1997, a total of 6 female patients [median age 62.5 years (range 30¿83)] with tumors on the body or tail of the pancreas underwent laparoscopic resection.The harmonic scalpel was used for dissection and hemostasis.After visualization of the pancreas, its inferior border was mobilized by opening the fatty tissue in the root of the mesentery of the transverse colon with the harmonic scalpel.The artery was mobilized and divided between four locking polydioxanone suture, absolok clips.The splenic vein was divided using absolok clips as it passed behind the pancreatic tail and just before its junction with the superior mesenteric vein.Postoperative complications included pancreatic leak (n=2) which both needed ct-guided drainage of peripancreatic collections with no surgical reintervention required; and pancreatic fistula (n=2) which healed conservatively, but total parenteral nutrition and prolonged hospitalization were required.The laparoscopic approach seemed appropriate for most benign distal pancreatic tumors.The patient was spared the large incision required for conventional surgery, and the specimen was often not large.A small amount of suturing is necessary, but no anastomosis was required.Spleen preservation on the vasa brevia was feasible laparoscopically.Technical difficulty was encountered with large tumors, and the closure of the pancreatic stump needed further study.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8540607
• MDR Text Key: 142869488
• Report Number: 3005075853-2019-18355
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• 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: 04/01/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other