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

Catalog Number	PPH01
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Septic Shock (2068); No Code Available (3191)
Date of Event	01/01/2004
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Publication year of 2004.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: pelvic sepsis after stapled hemorrhoidectomy authors: patrick pessaux, md; emilie lermite, md; jean-jacques tuech, md; olivier brehant, md; nicolas regenet, md; jean-pierre arnaud, md citation: j am coll surg.2004; 199(5): 824-5.Doi: 10.1016/j.Jamcollsurg.2004.04.026.A previously healthy (b)(6) year-old man underwent stapled hemorrhoidectomy done with pph 01 33-mm ethicon hemorrhoidal circular stapler (ethicon).Four days later, the patient was presented back at the emergency department complaining of rectal discomfort and perineal pain.The patient had septic shock and fever of 39.2 °c.Perineal examination showed extensive subcutaneous necrosis of the scrotum and inguinal area with crepitus on palpation.Ct showed a leakage from the staple line with extensive gas developing the rectum, bladder, and scrotum.The patient underwent emergency surgery.The rectum was inflated with water and povidone-iodine.Debridement and an end-colostomy were performed.Repeat necrosectomy and hyperbaric oxygen therapy were done during the stay.Culture of the necrotic tissue showed a polymicrobial infection (escherichia coli, bacteroides fragilis, and enterococci).The wound healed completely by 3 months.The patient presented with anal stenosis that required two dilations.It was reported that the perforation may have been a delayed ischemic phenomenon, related to crushing of the rectal wall by closure of the gun before final stapling.Usually the infection is polymicrobial, frequently with gas-forming organisms.It is possible that the firing of the stapler enabled gas-producing organisms in the rectal lumen to enter the pararectal space.Care must be taken to avoid incorporating more proximal prolapsing rectal mucosa into the jaws of the closing gun.Patients with anoreceptive sexual practices require appropriate advice.It is debatable whether anoreceptive sexual practice is a contraindication to stapled hemorrhoidectomy.Individuals should be warned that the presence of a circumferential staple line at the anorectal junction may make anal intercourse intolerable for both parties.The ¿go ahead¿ for anal sex should be given only after rectal digitation by the surgeon has confirmed that the staple line is correctly healed.Although this complication is exceptional, it must be included in consent information given to patients who are treated for hemorrhoid symptoms.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8842960
• Report Number: 3005075853-2019-20897
• Device Sequence Number: 14090479
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 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: Required Intervention