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

Catalog Number	PPH01
Health Effect - Clinical Codes	Hematoma (1884); Incontinence (1928); Pain (1994); 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: stapled transanal rectal resection to treat obstructed defecation caused by rectal intussusception and rectocele.Author/s: a.Renzi, d.Izzo, g.Di sarno, g.Izzo, n.Di martino.Citation: int j colorectal dis (2006); 21: 661¿667.Doi 10.1007/s00384-005-0066-5.This study was designed to determine the safety and efficacy of a modified stapled transanal rectal resection (starr) in patients with obstructed defecation syndrome (ods) caused by rectal-intussusception (ri) and/or rectocele (re).All the patients who underwent starr for ods caused ri and/or re were prospectively introduced into a database.Between june 2002 and february 2004, 68 patients (3 male and 65 female; mean age: 48.8±13.4 years; age range: 23¿77) with ods were observed.The modified starr procedure proposed reproduces the surgical technique proposed by antonio longo even if some modifications were suggested.Two pph-01 kits (ethicon) were utilized.Reported complication included failed to appose metallic agraphes (n-1) in which a handmade suture was necessary to complete the retrorectal anastomosis.Early complications included mild perineal hematoma (n-16) and bleeding (n-2).Reported late complications (3-month follow up) included urge to defecate (n-3) which spontaneously resolved within 6 months, incontinence to flatus (n- 2) which spontaneously resolved within 6 months, dyspareunia (n-1) which spontaneously resolved within 6 months, and rectal stenosis (n-1) which successfully treated by a new circular stapler resection.In conclusion, the surgical technique seems to be safe and effective, with a successful outcome in about 90% of the patients.However, despite these encouraging results, randomized trials and a longer follow-up are required to confirm starr as a good choice in the surgical treatment of ods caused by re and/or ri.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8859848
• Report Number: 3005075853-2019-20920
• Device Sequence Number: 1937956
• 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): 07/12/2019

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