MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR TRANSTAR STAPLER SET; STAPLE, IMPLANTABLE

Catalog Number	STR5G
Health Effect - Clinical Codes	Pain (1994); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.The single complaint was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.What is the specific number of patients in the d-pph and pph group who encountered the following perioperative complications mentioned in the article: pain, major bleeding, minor bleeding? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? (b)(4).
Event or Problem Description
Title : double pph technique for hemorrhoidal prolapse: a multicentric, prospective, and nonrandomized trial author : a.Braini, md, p.Narisetty, md , a.Favero, md, s.Calandra, md, a.Calandra, md, f.Caponnetto, md, f.Digito, md, f.Da pozzo, md, e.Marcotti, md, e.Porebski, md, s.Rovedo, md, g.Terrosu, md, l.Torricelli, md, and a.Stuto, md citation: doi: 10.1177/1553350612472988.Longo¿s technique (or pph technique) is well known worldwide.One of the reasons for the recurrence is the treatment of the advanced hemorrhoidal prolapse with a single stapling device, which is not enough to resect the appropriate amount of prolapse.The authors described the application of ¿double pph technique¿ (d-pph) to treat large hemorrhoidal prolapses.The authors performed a multicentric, prospective, and nonrandomized trial from july 2008 to july 2009.A total of 281 patients (142 male and 65 female patients; age range: 23 to 79 years old) with hemorrhoidal prolapse underwent surgery and were included in the study.Of which, 74 patients were assigned to the d-pph group and 207 patients underwent single pph.During the operative technique, the steps of d-pph is the same as the longo¿s technique (pph technique).Pph03 or pph01 circular stapler (ethicon) is introduced into the anal canal.The purse strings should not be tied around the stapler, but the ends must be pulled through the holes into the stapler head.In addition to the d-pph group, the procedure is technically similar with the stapled transanal rectal resection (starr) procedure performed with 2 devices.Nowadays, starr is preferably performed with contour transtar (ethicon).In the d-pph group, perioperative complications included pain 27.3%, major bleeding 4.1% requiring surgical intervention, and minor bleeding 49.3%; reported complications at 6 months follow-up included pain (n-4) and prolapse recurrence (n-2); reported complications at 1 year follow-up included pain (n-3) and prolapse recurrence (n-2).In the pph group, perioperative complications included pain 37.9%, major bleeding 3% requiring surgical intervention, and minor bleeding 36%; reported complications at 6 months follow-up included pain (n-1), major bleeding (n-2), minor bleeding (n-8), and prolapse recurrence (n-4); reported complications at 1 year follow-up included pain (n-5), major bleeding (n-1), minor bleeding (n-7), and prolapse recurrence (n-7).Hemorrhoids have been known and treated by surgeons for centuries, but no single classification of them can be described as perfect.According to the results of the present study, d-pph should be used in all patients suffering from hemorrhoidal prolapse without any symptoms of anorectal outlet obstruction, in which at the final evaluation under anesthesia the prolapse reaches or overcomes half of the volume of cad¿the anal dilator that is part of the pph kit (ethicon endo-surgery).The data shows that using d-pph and pph in selected patients will lower, in a significant way, the incidence of recurrence after a stapled hemorrhoidopexy approach.

• Brand Name: CONTOUR TRANSTAR STAPLER SET
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8730937
• Report Number: 3005075853-2019-20034
• Device Sequence Number: 2573040
• Product Code: GDW
• UDI-Device Identifier: 10705036002871
• UDI-Public: 10705036002871
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: STR5G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/25/2019
• 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