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

Catalog Number	PPH01
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Date of Event	01/01/2002
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Date of event: publication year of 2002.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: rectal perforation, retropneumoperitoneum, and pneumomediastinum after stapling procedure for prolapsed hemorrhoids: report of a case and subsequent considerations.Author/s: valter ripetti, m.D., marco caricato, m.D., augusto arullani, m.D.Authors: valter ripetti, m.D; marco caricato, m.D; augusto arullani, m.D.Citation: a complication of stapled hemorrhoidectomy, vol.45, no.2; pp268-270.This is a case study that discussed about rectal perforation, retropneumoperitoneum, and pneumomediastinum after stapling procedure for prolapsed hemorrhoids.A (b)(6) female patient presented with a history of outlet obstruction and pelvic floor descent.For six months she complained of rectal bleeding not related to evacuation.Preoperative colpocystodefecography showed pelvic floor descent, rectorectal intussusception, and anterior rectocele.Proctoscopy showed second-degree and third-degree hemorrhoids and mucosal prolapse.Anorectal manometry was normal.Procedure for prolapse and hemorrhoids (pph) device (ethicon) was used during the stapling procedure.Digital rectal examination showed a posterior rectal perforation on the staple line.The rectum was edematous and pararectal tissues were inflamed and vascular in which antibiotic therapy with vancomycin, metronidazole, and amikacin was started.At one month of follow-up, proctoscopy showed partial recovery of the rectal perforation.At three months of follow-up, a rectal stricture was diagnosed, which was treated with balloon dilation.In conclusion, the outcome of this case suggests that double firing of the stapler could predispose to rectal perforation because of the fixation of the rectal mucosa to the muscularis at the time of first stapling and subsequent stretching and laceration of the mucosa at the subsequent use of the device.Therefore, a double firing should be avoided.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9535009
• Report Number: 3005075853-2019-24843
• Device Sequence Number: 19667561
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Patient Age: 62 YR