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

Catalog Number	PPH01
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Sepsis (2067); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2006
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2006.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: low hemorrhoidopexy staple line does not improve results and increases risk for incontinence.Authors: f.Pigot, m.Dao-quang, a.Castinel, f.Juguet, d.Bouchard, j.Bockle and f.A.Allaert.Citation: tech coloproctol (2006) 10:329¿333; doi 10.1007/s10151-006-0302-1; published online: 27 november 2006.This prospective study aimed to assess the association between outcome of sh and patients¿ characteristics and procedure parameters (associated procedure, suture line height, doughnut size, presence of malpighian tissue or smooth muscle in specimen).Between december 2003 and june 2004, 68 patients with mean age 51 years, range 25-83 years (male n=56, female n=12) underwent sh.A mucosal doughnut was resected just above the apex of the internal hemorrhoids with a circular stapler (pph 01 or 03, ethicon endosurgery).Early complications included postoperative fissure (n=1) which required reoperation, local sepsis (n=2) which required operation and rectal bleeding (n=2) which was medically managed without blood transfusion.There was peroperative dysfunction of the stapler (n=1) which was corrected with manual mucosal anastomosis.At 4-week follow-up, complications included bleeding (n=9), prolapse (n=5) and pain (n=6) in which paracetamol (400 mg)-dextropropoxyphen (30 mg) (2 pills tid) and ketoprofen (150 mg bid) were prescribed.At 32-week follow up, complications included bleeding (n=9), prolapse (n=9) and pain (n=3) in which paracetamol (400 mg)-dextropropoxyphen (30 mg) (2 pills tid) and ketoprofen (150 mg bid) were prescribed.Further complications included anal incontinence (n=11), urgency (n=11), incontinence for liquid stool and flatus (n=2) and soiling and flatus incontinence (n=1).In conclusion, although the success rate of sh may not be influenced by technical variations, risk for moderate incontinence is elevated when the stapled line is low.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8860235
• Report Number: 3005075853-2019-21050
• Device Sequence Number: 1812048
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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