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

Catalog Number PPH01

Device Problem Use of Device Problem (1670)

Patient Problems Failure to Anastomose (1028); Fistula (1862); Pain (1994); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.

Event Description

It was reported via journal article: title : short- and long-term results of harmonic scalpel hemorrhoidectomy versus stapler hemorrhoidopexy in treatment of hemorrhoidal disease.Author : yusuf bilgin, semih hot*, _ilhami soykan barlas, arzu akan, yavuz eryavuz citation: asian journal of surgery.2015; 38: 214e219.Doi: http://dx.Doi.Org/10.1016/j.Asjsur.2014.09.004.In this prospective randomized study, the aim is to compare the short and long-term results of harmonic scalpel hemorrhoidectomy (hsh) and stapler hemorrhoidopexy (sh) methods in the surgical treatment of grade iii and grade iv hemorrhoidal disease.A total of 99 consecutive patients diagnosed with grade iii or grade iv internal hemorrhoidal disease were included in the study.Patients were randomized to hsh (n-48; mean age: 44.9 years; 28 male and 20 female patients) or sh (n-51; mean age: 44.3 years; 32 male and 19 female patients) treatments.During the surgical procedure in the hsh group, harmonic scalpel (ethicon) seals bleeding vessels and forms protein coagulum.When used in hemorrhoidectomy, this method minimizes bleeding of large hemorrhoids and decreases operative time.It was reported that sutures were not used.During the surgical procedure in the sh group, pph01 kit (ethicon), a purse-string suture anoscope (psa), a suture threader, and a 33-mm hemorrhoidal circular stapler, was used.The pursestring was done between 3 cm and 4 cm above the dentate line; the purse-string was completed with six to eight stitches, which included only the mucosal and submucosal layers, and hemostatic stitches using a vicryl 3-0 (ethicon) suture on a round body were used in case of bleeding.In the hsh group, reported short-term complication included bleeding (n-5); reported long-term complication included recurrence (n-1).In the sh group, reported short-term complications included post-operative pain (n-37), wound problems (n-8), and bleeding (n-8); reported long-term complications included recurrence (n-7) and perianal fistula (n-1).It was concluded that the hsh and sh are both safe and effective methods for surgical treatment of grade iii and grade iv hemorrhoidal disease.In the study, the hsh method was determined to be safer, easier, and faster to perform, and associated with fewer long-term recurrences than the sh method.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8721874
• MDR Text Key: 148791836
• Report Number: 3005075853-2019-19911
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036012993
• UDI-Public: 10705036012993
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K030925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PPH01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1