MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*HCS HEMORR CIR STAPL; STAPLE, IMPLANTABLE

Catalog Number	PPH01
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Itching Sensation (1943); Pain (1994); Thrombosis (2100); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2005
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Publication year of 2005.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 or Problem Description
It was reported via literature entitled: stapled hemorrhoidopexy vs.Diathermy excision for fourth-degree.Hemorrhoids: a randomized, clinical.Trial and review of the literature.Author : hector ortiz, jose marxo , pedro armendariz, mario de miguel.Citation: dis colon rectum (2005); 48: 809¿815.Doi: 10.1007/s10350-004-0861-z.The aim of this prospective study was to compare the results of stapled hemorrhoidopexy with those of conventional diathermy excision for controlling symptoms in patients with fourth-degree hemorrhoids.Between january 2001 and february 2002, 31 consecutive patients with fourth-degree hemorrhoids were enrolled in the study.The patients were randomized into two groups: 15 patients (8 male and 7 female; mean age: 47 years; age range: 28-69 years) underwent stapled hemorrhoidopexy and 16 patients (11 male and 5 female; mean age: 49 years; age range: 32-69 years) underwent diathermy excision.In stapled hemorrhoidopexy, the stapling procedure was performed according to the technique described by longo.The pph01 stapling gun (ethicon) was opened to its maximum position and introduced through the anus.A pursestring suture was tied on the stapler shaft, and the head of the instrument was closed on the anvil, incorporating the mucosal and submucosal tissue in the pursestring suture in the head of the gun.The stapler was then fired and gently withdrawn.Reported complications included minor staple-line bleeding (n-11) in which patients required hemostatic sutures, external hemorrhoidal thrombosis (n-1) which required medical treatment, fecal impaction (n-1) which required medical treatment, pain during the first 14 days (n-?), recurrent prolapse (n-8) in which 5 patients responded well to a later conventional diathermy hemorrhoidectomy, persistence of itching (n-6), tenesmus (n-6), hemorrhage (n-1), skin tags (n-10) and urgency (n-2).In conclusion, stapled hemorrhoidopexy was not effective as a definitive cure for the symptoms of prolapse and itching in patients with fourth-degree hemorrhoids.The conventional diathermy hemorrhoidectomy should continue to be recommended in patients with symptomatic, prolapsed, irreducible piles.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8845188
• Report Number: 3005075853-2019-20912
• Device Sequence Number: 19364963
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• PMA/510(K) Number: K030925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: PPH01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention