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

Catalog Number	PPH01
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Incontinence (1928); Pain (1994); 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 (starr): a new option in the treatment of obstructive defecation syndrome.Author/s: a.Ommer, k.Albrecht ,f.Wenger , m.K.Walz.Citation: langenbecks arch surg (2006); 391: 32¿37.Doi 10.1007/s00423-005-0004-6.The aim of this prospective study was to show the results of the new procedure stapled transanal¿rectal resection (starr).Within the scope of a prospective study, from january 2003 to june 2005, 14 consecutive patients (2 male and 12 female; mean age 53±12 years; age range: 28¿74 years) underwent stapled transanal rectal resection of the rectal wall.The operative technique in all cases was a modification of the stapled hemorrhoidopexy based on the longo procedure using pph01 (ethicon).Reported complications included secondary hemorrhage from the staple row (n-2) which could be controlled by direct transanal suture under general anesthesia, small and asymptomatic dehiscence of the ventral stapler row (n-1) which healed up without sequence, severe anal pain (n-1) which spontaneously ceased after 4 weeks, pain on operation day (n-?) in which five patients needed analgetic drugs such as morphine, and another four patients had to be given metamizole, pain on postoperative day 1 and day 2 (n-?) in which patients only needed mild analgesia (metamizole), diverticulosis and abdominal pain (n-1) in which the patient underwent sigmoid resection, urge incontinence (n-3), deterioration of preoperative normal continence (n-2), and new symptoms of liquid secretion (n-1).In conclusion, starr is an effective therapy for obstructive defecation disorder due to a symptomatic rectocele and/or a distal intussusception.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8843582
• Report Number: 3005075853-2019-20905
• Device Sequence Number: 11238765
• 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