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); Thrombosis (2100); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2011.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: long-term results after stapled hemorrhoidopexy: a prospective study with a 6-year follow-up.Authors: a.Ommer, m.D., jakob hinrichs, m.D., horst mollenberg, m.D., babji marla, m.D., martin karl walz, m.D.Citation: dis colon rectum (2011); 54: 601¿608.Doi: 10.1007/dcr.0b013e3182098df2.The study included consecutive patients who underwent stapled hemorrhoidopexy at our institution from may 27, 1999, through december 31, 2003.Stapled hemorrhoidopexy was performed in 257 consecutive patients (175 male and 82 female; mean age: 53 ±13; age range: 19-88 years) with grade iii hemorrhoids.The operating procedure was performed with a pph-01 stapler (ethicon).Reported complications included partial dehiscence (n-3) in which the row of staples had to be over sewn with interrupted sutures, residual hemorrhoidal nodules that had not been perfectly repositioned (n-18) which were removed by conventional resection, bleeding complications (n-10) requiring surgical intervention, hemorrhoidal thrombosis (n-1) in which the patient had a reoperation, incomplete repositioning (n-1) in which the patient received ventral mucosectomy, ventral staple was split (n-1) in which the patient had a reoperation, local pain (n-3) in which the patients had an anal revision, worsened incontinence (n-4), newly developed incontinence (n-11), worsened defecation disorder (n-4), newly developed defecation disorder (n-3) in which 1 patient could be cured by cutting the ventral staple line in a rectocele, newly developed bleeding (n-5), newly developed prolapse (n-12), recurrent prolapse (n-1) in which 1 patient had repeat stapled hemorrhoidopexy, worsened mucus discharge (n-1), newly developed mucus discharge (n-2), worsened burning (n-1), newly developed burning (n-6), newly developed itching (n-6), pain on the day of operation (n-?), pain on the first postoperative day and on the second post operative day (n-?).In conclusion, the long-term results show that this strategy for stapled hemorrhoidopexy can achieve a high level of patient satisfaction and symptom control, with a low rate of reoperation for recurrent hemorrhoidal symptoms.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8843559
• Report Number: 3005075853-2019-20899
• Device Sequence Number: 1948376
• 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