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

Catalog Number	PPH01
Health Effect - Clinical Codes	Abdominal Pain (1685); Edema (1820); Inflammation (1932); Sepsis (2067); Not Applicable (3189); No Code Available (3191)
Date of Event	01/01/2000
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2000.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: life threatening pelvic sepsis after stapled haemorrhoidectomy.Author/s: richard g molloy, david kingsmore.Citation: the lancet ¿ vol 355 ¿ march 4, 2000; 810.This study aimed to present a case of (b)(6) year-old male patient who underwent day-case stapled haemorrhoidectomy with 33-mm pph 01 stapling gun, ethicon, and developed severe pelvic sepsis.In the evening of the same day of haemorrhoidectomy, he developed a temperature of 38.5°c and was admitted for observation with intravenous antibiotics, but his condition failed to improve.He also complained of perineal, pelvic and lower abdominal pain.Computed tomography showed retroperitoneal gas enveloping the rectum.He was schedule for exploratory laparotomy.At operation, the pararectal tissues were inflamed, oedematous and vascular.At a point level with the staple line, a small pocket of pus was seen.Culture of the pus showed heavy growth of lactose fermenting coliforms, bacteroides fragilis and a clostridium (not c tetani or c perfringens).He made an uncomplicated recovery and was discharge 14 days after his haemorrhoidectomy.In such circumstances, infection, if present, might preferentially track into the pararectal tissues.Although we cannot be certain of the exact pathophysiology, no overt technical deficiencies in the operation were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8841308
• Report Number: 3005075853-2019-20878
• Device Sequence Number: 13829070
• 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): 07/09/2019

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: 07/09/2019
• 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: Hospitalization; Required Intervention