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 Hemorrhage/Bleeding (1888); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 1999.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: laparoscopic splenectomy for idiopathic thrombocytopenic purpura (itp).Author(s): c.J.Stanton.Citation: surg endosc (1999) 13: 1083¿1086.This retrospective study of 28 patients with itp who were managed by laparoscopic splenectomy (ls) was to evaluate an extended experience with the procedure and to document the long-term clinical outcomes.Between september 1992 and september 1997, twenty women and eight men with a mean age of 43 ± 20 years (range = 7¿75 years) comprised the study group.During the procedure, the right lateral decubitus position was utilized, with extensive use of the ultrasonic dissecting shears (harmonic scalpel, ethicon), late division of the splenic hilum, and (b)(6) bag extraction of the spleen at a subcostal trocar site.Ultrasonic dissection of retrosplenic peritoneal attachments, splenophrenic ligament, and the short gastric vessels allowed anteromedial mobilization of the spleen.Reported complications included hemorrhage (n=1) which required transfusion; failed to respond to ls (n=3) in which the two surgical failures responded to medical intervention and remained in clinical remission.In conclusion, laparoscopic splenectomy appears to have short- and long-term results equivalent to open surgery, as well as lower rates of major complications.The procedure is safe and efficacious, resulting in brief hospitalization, minimal recovery time, and excellent long-term results.

• 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 ; * 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: 9654417
• MDR Text Key: 190648946
• Report Number: 3005075853-2020-00670
• 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: 01/03/2020

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
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention