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

Catalog Number	PPH01
Health Effect - Clinical Codes	Pain (1994); Thrombosis (2100); Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Publication year of 2010.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: randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse authors: p.-o.Nystrom, n.Qvist, d.Raahave, i.Lindsey, n.Mortensen, on behalf of the stapled or open pile procedure (stopp) trial study group citation: british journal of surgery.2010; 97: 167¿176.Doi: 10.1002/bjs.6804.This multicenter randomized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of hemorrhoids.This study involved 207 patients that were randomized to either anopexy (age range: 21 to 86 years old; 47 male and 43 female patients) or milligan-morgan hemorrhoidectomy, of whom 90 in each group were operated on.For anopexy cases, a pph01 33-mm stapling device (ethicon) and kit utensils were used.In the anopexy group, reported complications included, daily pain (n-25.2), peak pain (n-41.7), excessive or protracted pain (n-2), excessive disturbance of bowel disfunction (n-14), post-operative bleeding (n-5) which required reoperation in 1 patient, anal stenosis (n-1) and was dilated, thrombosed residual hemorrhoid (n-3) which required excision in 2 patients, fissure (n-1), and prolapse (n-9) which required manual reduction.Hemorrhoidal prolapse was corrected equally by either operation.Diathermy hemorrhoidectomy gave better symptom relief but was more painful.Neither operation provided complete cure but well-being was greatly improved.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8856562
• Report Number: 3005075853-2019-20919
• Device Sequence Number: 2515659
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: 08/02/2019
• 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