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

Catalog Number	PPH01
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	01/01/2003
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Date of event: publication year of 2003.Batch # unk.This report is related to a journal article, therefore no product will be returned for analysis and the batch history 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: day-case stapled (circular) vs.Diathermy hemorrhoidectomy, a randomized, controlled trial evaluating surgical and functional outcome.Author/s: matti kairaluoma, m.D., ph.D., yosti nuorva, m.D., ph.D., ilmo kellokumpu, m.D., ph.D.Citation: dis colon rectum 2003; 46:93¿99.The aimed of this randomized, controlled study to compare the efficacy and value of stapled hemorrhoidectomy with that of diathermy hemorrhoidectomy in a day-case.Between april 1999 and august 2000, 60 patients were enrolled in the study in which 30 patients (male=19, female=11; mean age=48.5 years, age range=17-65 years) underwent diathermy hemorrhoidectomy and 30 patients (male=13, female=17; mean age=47 years, age range=25-65 years) stapled hemorrhoidectomy.The patients underwent either conventional hemorrhoidectomy with diathermy dissection and without pedicle ligation or stapled hemorrhoidectomy by means of the pph01 stapling device (ethicon).Reported complications included minor secondary bleeding from the staple line (n=2) on days 1 and 7 after surgery and was treated by adrenaline injection; anastomotic stenosis (n=1) and was treated by balloon dilatation; treatment failures (n=7) which necessitated subsequent treatments.In conclusion, stapled hemorrhoidectomy is a significantly less painful operation than diathermy hemorrhoidectomy but does not seem to offer significant advantages in terms of hospital stay or symptom control in the long term.Hemorrhoidectomy may improve symptoms of difficult rectal evacuation.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9534989
• Report Number: 3005075853-2019-24842
• Device Sequence Number: 3542453
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 12/09/2019

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: 12/09/2019
• Initial Report FDA Received Date: 12/31/2019
• 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