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); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2005
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: 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
Title: prospective randomised clinical trial of single versus double purse-string stapled mucosectomy in the treatment of prolapsed haemorrhoids.Authors: francisco pérez-vicente, antonio arroyo, pilar serrano, fernando candela, ana sanchez and rafael calpena.Citation: int j colorectal dis (2006) 21: 38¿43; doi 10.1007/s00384-004-0720-3; published online: 21 april 2005.This prospective randomized clinical trial aimed to compare the outcomes after single purse-string csm versus double purse-string csm.Between may 2000 and june 2002, one hundred consecutive patients (male n=63, female n=37, mean age 50.70 years) were randomized to single purse-string csm (group 1, n=50, male n=34, female n=16, with mean age 49.50 years) versus double purse-string csm (group 2, n=50, male n=29, female n=21, with mean age 51.92 years.The operation was carried out according to the technique initially described by longo utilizing a 33-mm circular stapling device (pph 33-01, ethicon endosurgery).Complications in the single purse group included anastomotic bleeding requiring transfixive suture (n=14), staple suture defect (n=2), pain on defecation (n=14), frequent bleeding postoperative (n=7), daily bleeding postoperative (n=2) in which one patient was taken back to the operating theatre within the first 12 postoperative hours; incontinence (n=7) which spontaneously reversed with no treatment, persistent pain (n=3) in which one patient had removal of several staples that were too close to the dentate line and residual prolapse/recurrence (n=2) in which one patient underwent another csm and the other patient underwent a milligan ¿ morgan procedure.In the double purse group, complications included anastomotic bleeding requiring transfixive suture (n=23), staple suture defect (n=1), pain on defecation (n=9), frequent bleeding postoperative (n=7) and incontinence (n=5) which spontaneously reversed with no treatment.In conclusion, double purse-string csm resects a greater doughnut and increases the distance of the staple suture from the dentate line in comparison to single purse-string csm, improving results in terms of early postoperative pain.Larger series should be necessary to assert whether recurrence is lower.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8843568
• Report Number: 3005075853-2019-20903
• Device Sequence Number: 19354964
• 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: 07/30/2019
• 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