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 Failure to Anastomose (1028); Incontinence (1928); Unspecified Infection (1930); Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2007.Medical device: 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.[(b)(4)].

Event Description

It was reported via literature entitled: laparoscopic ventral rectopexy, posterior colporrhaphy and vaginal sacrocolpopexy for the treatment of recto-genital prolapse and mechanical outlet obstruction.Author : s.Slawik, r.Soulsby, h.Carter¿, h.Payne¿ and a.R.Dixon.Citation: colorectal disease (2007); 10:138¿143.Doi:10.1111/j.1463-1318.2007.01259.X.Whilst trans-abdominal fixation resection offers better functional results and lower recurrence than perineal procedures, mesh rectopexy is complicated by constipation.Laparoscopic autonomic nerve-sparing, ventral rectopexy allows correction of the underlying abnormalities of the rectum, vagina, bladder and pelvic floor.Between january 1997 and december 2005, 80 patients (6 male and 74 female; median age: 59 years; age range: 31¿90 years; bmi: 19¿36) underwent novel laparoscopic prolapse surgery for full thickness prolapse and/or mechanical outlet obstruction.A harmonic scalpel (ethicon) is used for the dissection.A 15x15 cm prolene polypropylene mesh (ethicon) is trimmed in the hypotenuse axis to 3x17 cm, the last 7 cm tapering to 1 cm.The mesh is sutured to the ventral aspect of the seromuscular wall of the rectum using three, interrupted, non-absorbable sutures ethibond 0 (ethicon).The posterior wall of the vagina is then sutured to the ventral aspect of the mesh with three sutures as before.The most cranial is sutured to the posterior vaginal fornix.The tapered end of mesh is fixed to the sacral promontory without placing any particular traction on the rectum.During the resection rectopexy, the upper 1/3 of the rectum is divided using a linear cutter (ethicon).The umbilical port is extended either side of the umbilicus in the midline to allow delivery of the bowel.The proximal bowel and head of a circular stapling device (ethicon) is returned to the abdominal cavity and the incision is closed around the re-introduced umbilical port.Reported complications included fecal impaction (n-3), extraction port site infection (n-1), wound infection (n-2%), bleeding (n-1), resection rectopexy anastomosis leaked (n-1) which required a temporary loop ileostomy, urinary retention (n-1), minor evacuatory difficulties (n-3) which were managed with a combination of senna and enemas.And two, urinary stress incontinence (n-2) which responded to a tvt sling.In conclusion, laparoscopic ventral rectopexy is safe with relatively low morbidity.In the medium-term, it provides good results for prolapse and associated symptoms of incontinence and obstructed defecation.

• 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: 8904385
• MDR Text Key: 154703652
• Report Number: 3005075853-2019-21327
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2019

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
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention