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

Catalog Number	PPH01
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2007.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: impact of stapled haemorrhoidopexy on stool continence and anorectal function¿long-term follow-up of 242 patients.Authors: stefan riss, philipp riss, michael schuster, thomas riss.Citation: langenbecks arch surg.2008; 393: 501¿505.Doi: 10.1007/s00423-007-0257-3.Several studies have proved the feasibility and safety of stapled anopexy for treating hemorrhoidal prolapse.However, stool urgency and fecal incontinence as possible side effects are still debated.The present study was designed to assess the impact of longo¿s procedure on stool continence and anorectal function.From 1999 to 2005, a total of 242 patients (100 female and 142 male patients; age range: 29 to 94 years) underwent stapled hemorrhoidopexy for symptomatic hemorrhoidal prolapse.During the surgical procedure, the anus is gently dilated by using the obturator.Perianal traction sutures are inserted at 3, 6, 9 and 12 o¿clock to fix the cad 33 circular anal dilatator (ethicon).By means of a psa 33 special side open anoscope (ethicon), a purse string suture is inserted into the mucous membrane of the distal rectum, about 2¿3 cm above the hemorrhoidal tissue.Using a pph 01 circular stapler device (ethicon), a mucosal doughnut is resected.The resulting stapler line is situated approximately 2 cm above the dentate line.Reported complications included bleeding (n-3) which required re-operation, anal stenosis (n-2) and were dilated successfully, recurrent hemorrhoidal prolapse (n-5) and were operated with an mm procedure, residual skin tags (n-65), recurrent bleeding (n-19), pain (n-8), and itching (n-10).The present data revealed no significant negative impact of longo¿s technique on anorectal function.In contrast, the incontinence score showed a slight improvement without a statistical significance.According to the evacuation score, the results showed a significant improvement of evacuation.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8860587
• Report Number: 3005075853-2019-21052
• Device Sequence Number: 1811489
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/12/2019

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: 07/12/2019
• Initial Report FDA Received Date: 08/05/2019
• 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