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

Catalog Number	PPH01
Health Effect - Clinical Codes	Hematoma (1884); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2009.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: new approach to large haemorrhoidal prolapse: double stapled haemorrhoidopexy.Authors: gabriele naldini, jacopo martellucci, pasquale talento, angelo caviglia, luca moraldi, mauro rossi.Citation: int j colorectal dis (2009); 24:1383¿1387.Doi: 10.1007/s00384-009-0750-y.The aims of this study were to verify if in large haemorrhoidal prolapses (independent from degree) in patients with no symptoms of obstructed defaecation syndrome (ods), the use of a stapled haemorrhoidopexy variant, comprising a double stapler haemorrhoidopexy (dsh), makes it possible to reduce the percentage of failures or relapses; and to standardise an objective intraoperative parameter for the purpose of quantifying internal prolapses which can then be used as a guide in determining the type of treatment to be provided.Between june 2003 and june 2004, 353 patients (97 male and 256 female; mean age: 47; age range: 20-76) were operated in three centres for haemorrhoidal prolapse.The occupation of more than half of the length of the circular anal dilator (cad) of a set pph 01 (ethicon) by prolapse during the evaluation under anaesthesia was taken as an objective parameter for establishing the extent of the prolapse and the indication to dsh.Eighty-three patients underwent dsh (dsh group) and 270 patients underwent stapled anopexy (sa group).Reported complications in the dsh group included residual illnesses/residual disease/residual prolapse (n-3), relapse illness/ relapsed prolapse/recurrence of prolapse (n-5), urgency at <3 months (n-6), postoperative bleeding with necessity of haemostasis revision (n-2) and, rectal haematoma spontaneously drained (n-1).In the sh group, reported complications included residual illness/residual prolapse (n-9), relapsed illness/recurrence of prolapse (n-12), urgency at <3 months (n-18), postoperative bleeding with necessity of haemostasis revisions (n-7), and rectal haematoma spontaneously drained (n-2).In conclusion, the intraoperative selection criterion was both efficacious and reproducible.This variant technique, which can be used in large haemorrhoidal prolapses, could allow for further improvement in the quality of treatment for haemorrhoidal conditions using stapled haemorrhoidopexy, without increasing the complications.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8855961
• Report Number: 3005075853-2019-20929
• Device Sequence Number: 2499106
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/10/2019

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: 07/10/2019
• Initial Report FDA Received Date: 08/02/2019
• 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